Fact check: Has Neurocept received FDA clearance or approval and what type (510(k), PMA, De Novo, EUA)?

1. Why the claim “Neurocept is FDA-approved” collapses under inspection

The Neurocept product page explicitly uses the statutory language typical of dietary supplements: “not evaluated by the Food and Drug Administration” and “not intended to diagnose, treat, cure, or prevent any disease.” That language is a strong regulatory indicator that Neurocept is being marketed as a supplement regulated under food law rather than as a medical device or drug subject to premarket approval. The available site excerpt contains no mention of a 510(k) Premarket Notification, a Premarket Approval (PMA), a De Novo classification request, or an Emergency Use Authorization (EUA). Where a company had a cleared device or an approved drug, standard practice is to reference the specific FDA decision and its identifier; that evidence is absent here ^[1].

2. Company filings exist but do not equate to clearance—what the filings show and don’t show

Neurocatch Inc. maintains a public page listing recent FDA filings, including categories like Premarket Notifications, Premarket Applications, De Novo applications, and GUDID registrations, which signals active engagement with FDA processes but not automatic approvals. The record excerpts indicate submissions or that filings are catalogued, yet none of the materials provided confirm a positive FDA outcome for Neurocept. A submission or listing in an FDA database is not the same as a successful 510(k) clearance, PMA approval, or De Novo grant; the provided filings lack conclusive entries tying Neurocept to any of those clearance types ^[2].

3. How FDA pathways differ and why Neurocept’s language suggests the supplement pathway

The FDA routes—510(k), PMA, De Novo, and EUA—apply to medical devices or drugs requiring demonstrated safety and efficacy for specific indications. A 510(k) shows substantial equivalence to a predicate device; a PMA requires clinical evidence of safety and effectiveness for high-risk devices; De Novo is for novel low- to moderate-risk devices without predicates; EUA is temporary, granted in declared emergencies. Neurocept’s labeling as a supplement and the explicit FDA disclaimer align with regulation under the Dietary Supplement Health and Education Act, not device or drug premarket pathways, which is consistent with the absence of any of the named approvals in the cited records ^{[1] [3]}.

4. Other public records reviewed and what they do not indicate

Additional searches and documents provided include medical-device listings and unrelated device approvals—examples such as the Neuroguard IEP System entry demonstrate how FDA clearances are publicly documented with identifiers when granted. Those device-approved entries are concrete and dated; by contrast, no comparable entry or identifier is present for Neurocept in the materials assembled, which reinforces that Neurocept has not been publicly recorded as cleared or approved under any of the FDA device or emergency authorization pathways in the cited documents ^{[4] [3]}.

5. Commercial framing and potential agendas to note for readers

Marketing a product as a “supplement” while referencing clinical-sounding benefits without FDA evaluation can create consumer confusion about oversight and efficacy. The company’s page and its listings of filings could be construed as signaling legitimacy, but absent a named FDA decision (510(k) number, PMA letter, De Novo grant, or EUA), the practical effect is that Neurocept has no documented FDA clearance or approval in the materials provided. Readers should treat claims of regulatory status critically: the company may emphasize filings or research activities to imply progress toward regulatory acceptance, but the evidence here does not show completion of such a pathway ^{[1] [2]}.

6. Bottom line and next steps for verification

Based on the available documentation, Neurocept has not been shown to possess FDA 510(k), PMA, De Novo, or EUA authorization; the product is presented as a dietary supplement with the standard FDA disclaimer, and company filings listed publicly do not prove an approved regulatory outcome. For definitive verification, consult the FDA’s searchable databases (510(k) Premarket Notification, PMA, De Novo, EUA, and the National Drug Code and Dietary Supplement listings) for the most current entries and identification numbers; absent such an entry linked to Neurocept, no FDA clearance or approval exists in the cited records ^{[3] [1]}.