What FDA authorizations or 510(k)/PMA submissions has Neurocept Inc. made by 2025?

1. What the public FDA records you provided cover — and what they don’t

The supplied FDA pages and industry roundups include comprehensive lists of 2025 device clearances, drug approvals and regulatory guidance — for example, the FDA’s index of cleared 510(k) submissions for 2025 and multiple “FDA Action Update” summaries used by trade outlets to track agency activity — yet none of those specific documents or summaries in your dataset identify Neurocept Inc. as a filer or recipient of authorization ^{[1] [2] [3]}. That means the available materials either omit Neurocept entirely or the company did not make a public 510(k)/PMA/authorization listed in these sources through 2025 (available sources do not mention Neurocept; p1_s7).

2. How to interpret silence in these records

Silence in the supplied documents can mean several things: Neurocept may not have filed any 510(k) or PMA submissions that resulted in a clearance or approval during 2025; the company might have filed but the decision or listing is not included in the specific extracts you provided; or Neurocept’s filings, if any, may appear in other FDA databases or later updates outside the supplied set (available sources do not mention Neurocept; ^[4]; p1_s7). The FDA’s public 510(k) index and action updates are authoritative for items they list, but they are not a guaranteed complete snapshot unless you query the full FDA databases directly ^{[4] [1]}.

3. What the agency sources you provided actually do show about 2025 device activity

The FDA maintains a cleared 510(k) submissions list for 2025, and the device guidance pages explain how 510(k) and PMA processes work, including eSTAR electronic submissions and review timelines — context useful for understanding what a Neurocept filing would look like if present ^{[1] [4] [5]}. Trade reporting (NeurologyLive summaries) chronicles accepted NDAs, clearances, and designations in neurology for 2025 but does so by naming the companies involved; those roundups list many firms yet do not list Neurocept in the excerpts you supplied ^{[2] [3]}.

4. Competing explanations and what each would imply

If Neurocept had a public FDA clearance or PMA in 2025, it would likely appear on the FDA’s cleared 510(k) list or in trade updates; the absence in these sources therefore weighs against such an event ^{[1] [2]}. Alternatively, Neurocept could have pursued other regulatory paths not captured here — for example, pre-submission Q-Sub interactions, IDEs, foreign approvals, or filings in late 2025 that are not yet reflected in the provided extracts — and those would not be visible in the current dataset (available sources do not mention Neurocept; p2_s3).

5. Next steps to verify — where to look and why it matters

To confirm definitively whether Neurocept made any FDA filings by 2025, query the FDA’s main public databases directly: the CDRH 510(k) database and the PMA database, and search the CBER/CBER/BLA pages if the product could be a biologic; also check FDA press releases and the company’s own SEC filings or press statements if it is publicly reporting regulatory milestones ^{[4] [5]}. Trade outlets that publish monthly “FDA Action Updates” (like NeurologyLive) are useful cross-checks for neurology-focused activity but should not be the sole source ^{[2] [3]}.

6. Caveats, limitations, and potential bias in the supplied material

The material you provided mixes high-level FDA pages, device-process guidance, and trade reporting excerpts; none is a targeted search for Neurocept, and several items are truncated summaries rather than full database extracts — so absence of evidence in this batch is not absolute proof of absence (available sources do not mention Neurocept; ^[1]; p2_s3). Also note that trade summaries focus on notable or high-profile actions and may omit smaller device clearances, so a small 510(k) could be missed in those outlets even if it appears in FDA records ^{[2] [3]}.

If you want, I can (a) search the FDA 510(k) and PMA/MAUDE databases for any Neurocept entries from 2020–2025 using the full public indexes, or (b) draft an email template you can send to Neurocept or the FDA FOIA office requesting confirmation; tell me which you prefer.