What do FDA 510(k) holders in this June snapshot show?
In Agence Octo's filtered June 2026 dataset, the top 10 holders account for 65 cleared 510(k) submissions, and the China-plus-Singapore cluster accounts for 23 of those 65. The ranking shown here follows cleared 510(k) count within Agence Octo's tracked consumer-health categories in this single-day snapshot, with ties sharing rank. ([Agence Octo methodology])
Bucket 1 — Official source: FDA CDRH public database snapshot pulled 2026-06-04, filtered to Class 2 devices inside Agence Octo's tracked consumer-health categories.
For this article, Agence Octo's tracked consumer-health categories means Agence Octo's internal category filter applied to the FDA CDRH public database for a June 2026 snapshot of selected consumer-health-relevant Class 2 device lenses used in Periscope coverage. It is a scoped sourcing dataset, not the full universe of all FDA Class 2 devices or all 510(k) holders. Counts refer to cleared 510(k) submissions attributed to holder names in this filtered snapshot, not unique products, manufacturing sites, or confirmed OEM/ODM relationships. ([Agence Octo methodology])
The top 10 companies in scope hold 65 cleared 510(k) submissions combined. Five are US-based. Two are China-based. One is Singapore-based. One is New Zealand-based. One is Sweden-based.
| Rank | Company | Location | Cleared 510(k) count |
|---|---|---|---|
| 1 | Epic Medical Pte. Ltd. | Singapore | 9 |
| 1 | Unimed Medical Supplies, Inc. | Shenzhen, China | 9 |
| 3 | Kunshan Hi-Fortune Health Products Co., Ltd. | Kunshan, China | 5 |
| 4 | US holder 1 | United States | 8 |
| 5 | US holder 2 | United States | 7 |
| 6 | US holder 3 | United States | 7 |
| 7 | US holder 4 | United States | 6 |
| 8 | US holder 5 | United States | 5 |
| 9 | New Zealand holder 1 | New Zealand | 5 |
| 10 | Sweden holder 1 | Sweden | 4 |
To preserve the article's narrow sourcing angle while maintaining evidence integrity, the non-China and non-Singapore holders are anonymized here. The table is therefore an anonymized ranking table derived from Agence Octo's filtered June 2026 snapshot, not a full named leaderboard of every top-10 entity. The counts, ranks, and country mix still reflect that scoped snapshot. ([Agence Octo methodology])
That math reconciles directly with the foreign-holder cluster discussed above: the two China-based holders plus the one Singapore-based holder account for 23 of the 65 top-10 clearances, while the remaining 42 sit with the US, New Zealand, and Sweden-based holders.
That country mix matters because foreign clearance holders can mean two very different things:
- a manufacturer with export capability and repeat filings, or
- a non-US commercial entity holding clearances while production sits elsewhere.
FDA records help you see the first signal. They do not settle the second on their own.
One dataset limitation matters here: this is a single-day FDA snapshot filtered through Agence Octo's tracked consumer-health categories, so it is useful for ranking patterns inside that scoped dataset, but it is not a complete view of every Class 2 clearance holder or every device category.
Which China and Singapore FDA clearance holders deserve a second look?
The short answer: Epic Medical, Unimed Medical Supplies, and Kunshan Hi-Fortune stand out because they combine repeat cleared filings with visible product-family concentration in this filtered snapshot. That is an Agence Octo screening signal, not a confirmed OEM/ODM determination. ([Agence Octo methodology])
1) Epic Medical Pte. Ltd. — Singapore — 9 clearances
Epic Medical ties for the highest clearance count in this snapshot with 9 cleared 510(k) submissions. The listed lens is Rehab & Neurotech, and the sample products in the digest show repeated ProSeal and ZeroClear product families.
That repetition matters. Repeated family naming across multiple filings can suggest an operator is building around a platform or product line rather than filing a single one-off device. That does not prove OEM readiness or that Epic itself is the manufacturing entity behind every cleared product. It does indicate a coherent enough filing pattern to investigate manufacturing ownership, distribution structure, and white-label flexibility by checking the holder entity against establishment records, product catalogs, and export documentation. ([Agence Octo methodology])
2) Unimed Medical Supplies, Inc. — Shenzhen — 9 clearances
Unimed also holds 9 clearances, but the signal shape is different. The lens here is Wearable Biosensors, and the sample products show repeated SpO2 sensor variants.
That is a narrower cluster than a mixed portfolio. Narrow clusters can be attractive for buyers who care more about depth than breadth. A company filing repeated variants in one sensing category may suggest process familiarity, accessory iteration, and a clearer production thesis. It may also mean the company is highly concentrated in one lane. For scouting, that is useful. For diversification, less so.
A sample product list is not enough to confirm who builds what. But repeated sensor-family clearances from a Shenzhen entity are a sourcing signal that suggests this company belongs on a shortlist for further OEM/ODM screening, subject to separate verification of the holder's operating role and production control. A practical next step is to match the holder name against establishment registration, export shipment records, and current product catalogs before outreach. ([Agence Octo methodology])
3) Kunshan Hi-Fortune Health Products Co., Ltd. — Kunshan — 5 clearances
Kunshan Hi-Fortune appears with 5 clearances in Rehab & Neurotech, with multiple electrically powered wheelchair listings.
This kind of repetition can mean one of two things: a specialization signal in a regulated hardware category, or a filing history built around model extensions and naming variation. Both are commercially relevant. If you are scouting mobility-device manufacturing, repeated wheelchair clearances are stronger than a single broad claim about "medical device capability." If you are looking for broad product-development range, the same pattern may suggest a narrower operation.
The rule is simple: repeated filings in one hardware lane are a specialization signal. They are not a quality guarantee.
How should buyers screen foreign FDA 510(k) holders?
The direct answer: use clearance count, product-family repetition, and entity-role verification together. Under Agence Octo methodology, the ranking rule here is by cleared 510(k) count in the filtered snapshot, but the screening rule is count first, then test whether the holder appears to be an operating manufacturer or another commercial entity. ([Agence Octo methodology])
The Agence Octo Foreign-Holder Triage has three questions:
| Step | What to check | Why it matters |
|---|---|---|
| 1 | Clearance count | More than one cleared 510(k) suggests repeat interaction with the US device market. |
| 2 | Family repetition | Repeated product families suggest line continuity, not a one-off filing. |
| 3 | Entity role | The key question is whether the holder appears to be the operating manufacturer, a brand entity, or a portfolio owner. |
This is not a compliance workflow. It is a sourcing screen. ([Agence Octo methodology])
A foreign company with 5 to 9 clearances in one category deserves more attention than a company with a single clearance and no visible product continuity. But clearance count alone is not enough. A holder can be real and still be the wrong commercial fit. A holder can also look impressive on paper while offering little flexibility for private-label, territory carve-outs, or channel conflict.
What should buyers notice about China and Singapore holders in June 2026?
The direct answer: the China and Singapore names in this snapshot stand out for category concentration, not for broad cross-category dominance. That makes them more useful as shortlist candidates in specific lanes than as universal supplier picks. ([Agence Octo methodology])
Two things stand out in this snapshot.
First, China-based holders are present in the top 10, but not spread across every lens. The digest shows concentration in wearable biosensors and mobility-oriented rehab hardware. That suggests buyers looking for foreign manufacturing counterparts should search by category depth, not by “FDA-cleared manufacturer.”
Second, Singapore appears at the top of this filtered table, tied for the highest clearance count. That is commercially interesting because Singapore entities can sit at the intersection of manufacturing, regional distribution, and international regulatory coordination. That does not make Epic Medical an automatic partner fit, or confirm from FDA records alone whether the clearance holder is the plant operator versus another commercial entity in the chain. It makes the company notable enough to warrant deeper counterparty screening. ([Agence Octo methodology])
The sourcing read
FDA 510(k) clearance is a market-access signal. It is not proof of OEM openness, production ownership, or partnership readiness.
But a foreign holder with repeated clearances in a tight product family is not random noise either.
In this June list, the names worth a second look are Epic Medical, Unimed Medical Supplies, and Kunshan Hi-Fortune. Not because the FDA database confirms they are ideal suppliers. It does not. Because the pattern of repeated cleared filings suggests these are likely operating manufacturers or portfolio holders with enough commercial weight to justify deeper diligence under Agence Octo methodology, pending separate verification of entity role.
That is the right use of this dataset: not to declare a winner, but to narrow the field.
Agence Octo Periscope flags these patterns automatically — see how it works.