Which companies top this June 2026 snapshot?
Per the FDA CDRH public database snapshot dated 2026-06-04, the top 10 companies in Agence Octo's tracked consumer-health categories account for 65 cleared 510(k) submissions combined. Based on Agence Octo's June 2026 snapshot methodology, the leaders are:
| Rank | Company | Country | Cleared 510(k)s in snapshot | Agence Octo category lens |
|---|---|---|---|---|
| 1 | Epic Medical Pte. Ltd. | Singapore | 9 | Rehab & Neurotech |
| 2 | Fisher & Paykel Healthcare, Ltd. | New Zealand | 9 | Respiratory & Sleep |
| 3 | Unimed Medical Supplies, Inc. | China | 9 | Wearable Biosensors |
| 4 | Cepheid | United States | 6 | Home Diagnostics; Respiratory & Sleep |
| 5 | Roche Molecular Systems, Inc. | United States | 6 | Home Diagnostics; Respiratory & Sleep |
| 6 | Sleepnet Corporation | United States | 6 | Respiratory & Sleep |
| 7 | Abbott Molecular, Inc. | United States | 5 | Home Diagnostics; Respiratory & Sleep |
| 8 | Breas Medical AB | Sweden | 5 | Respiratory & Sleep |
| 9 | Kunshan Hi-Fortune Health Products Co., Ltd. | China | 5 | Rehab & Neurotech |
| 10 | Medline Industries, LP | United States | 5 | Rehab & Neurotech; Respiratory & Sleep |
Source: FDA CDRH public 510(k) database snapshot, filtered to Class 2 devices in Agence Octo-tracked categories; category mapping and company grouping follow Agence Octo's June 2026 snapshot methodology ([Bucket 1: official] + [Bucket 4: Agence Octo methodology]). Method note: counts reflect Agence Octo's company-level grouping of cleared submissions visible in this dated snapshot, not an FDA-issued company ranking.
These counts represent cleared 510(k) submissions attributed to each company in this specific snapshot after Agence Octo filtered the public FDA records to its tracked consumer-health categories. They are snapshot counts, not lifetime proof of capability, manufacturing ownership, or current commercial availability.
For context, the distribution in this snapshot is:
- 86 reviewed companies in Agence Octo's tracked consumer-health categories
- 10 companies in the concentration table
- 86 total cleared 510(k) submissions in the 86-company review set
- 65 cleared 510(k)s attributed to those top 10 companies combined
- About 76% of the cleared submissions in this 86-company review set are concentrated in the top 10
| Methodology / limitation | What it means here |
|---|---|
| Snapshot date | FDA CDRH public 510(k) database snapshot dated 2026-06-04 |
| Filter scope | Class 2 devices within Agence Octo-tracked consumer-health categories |
| Review set | 86 distinct companies after Agence Octo company grouping within the filtered snapshot |
| Concentration denominator | 86 total cleared 510(k) submissions counted within that 86-company review set |
| Company attribution | Agence Octo grouping layer; not an FDA-issued company ranking or ownership determination |
| Not shown by this screen | Supplier quality, OEM status, factory control, commercial readiness, or full historical clearance totals |
The Agence Octo Clearance Concentration Screen
Use three bands.
| Band | Clearance count in this snapshot | What it suggests | What it does not prove |
|---|---|---|---|
| Tier 1 | 9 | Repeat filing footprint visible at a glance | OEM readiness, commercial availability, or partner fit |
| Tier 2 | 6 | Sustained activity in at least one tracked lens | Manufacturing ownership or white-label openness |
| Tier 3 | 5 | More than a one-product appearance | Current export capacity or willingness to onboard new brands |
A repeated name in the FDA database is a sourcing signal. It is not regulatory confirmation of your exact use case. The screen is there to rank attention, not to replace diligence.
Why the 9-clearance cluster matters
Three companies sit at the top with 9 cleared submissions each: Epic Medical Pte. Ltd., Fisher & Paykel Healthcare, Ltd., and Unimed Medical Supplies, Inc.
That tie matters more than the exact count.
When three different companies from three different geographies reach the same visible filing volume in one snapshot, buyers can read it as concentration rather than a one-company spike. One company can spike because of a single product family. Multiple companies clustering at the same high count is a useful indicator of an active competitive lane with repeat submissions already in motion in this snapshot ([Agence Octo methodology]).
The companies are also spread across different lenses:
- Epic Medical Pte. Ltd. — Rehab & Neurotech
- Fisher & Paykel Healthcare, Ltd. — Respiratory & Sleep
- Unimed Medical Supplies, Inc. — Wearable Biosensors
That spread suggests the repeat-filing pattern is not limited to one narrow subcategory in this snapshot. It appears across several tracked consumer-health lanes in the June snapshot.
Buyer action screen
After the ranking, run one quick operator screen before outreach:
- Confirm the company shows up in your target category lens, not just an adjacent one
- Check whether the repeated filings map to one product family or multiple SKUs or platforms relevant to your brief
- Treat FDA filing visibility as a sourcing signal, not as proof of OEM fit, factory control, or program readiness
Geography is useful. It is not enough.
The country split in the top 10 is:
- United States — 5 companies
- China — 2 companies
- Singapore — 1 company
- New Zealand — 1 company
- Sweden — 1 company
Country is a screen, not a verdict.
A China- or Singapore-based company in this snapshot may be commercially interesting to buyers looking for manufacturing-side counterparties. A US-based company in this snapshot may be commercially interesting to buyers tracking brand owners, platform builders, or category incumbents. But geography alone does not prove who owns the factory, who controls design history, or who is open to a private-label discussion.
Watch the filing stack, not any single label.
The category pile-up is the bigger commercial clue
Respiratory & Sleep appears across 7 of the 10 companies in the digest. Rehab & Neurotech appears across 3. Home Diagnostics appears across 3. Wearable Biosensors appears once.
That matters because concentration by company and concentration by category can reinforce each other.
If a company sits in a crowded lens and still shows repeat clearances, it may suggest staying power against active peers. If a company sits in a thinner lens but still reaches the top tier, it may indicate a narrower but deeper product program ([Agence Octo methodology]).
For June 2026, Respiratory & Sleep is the clearest example of category crowding in Agence Octo's classification layer. Buyers scouting that lane should expect more overlap, more incumbent depth, and less signal value from any single clearance announcement.
What buyers should do with this list
Use this list to decide who deserves a second look.
Do not use it to assume partnership readiness.
A company with 5 to 9 cleared 510(k)s in the FDA CDRH public database has shown visible repeat filing activity in a tracked lane. That is enough to justify commercial research. It is not enough to conclude that the company is compliant for your market, available for OEM work, or suitable for clinical claims.
The practical read is simple:
- Start with repeated names, not isolated names.
- Compare the company's clearance count with its category lens.
- Separate filing visibility from partnership fit.
- Treat every FDA-derived signal as one layer in the sourcing stack.
The fastest mistake is to chase the newest name. The better move is to watch who keeps showing up.