What regulatory actions or FDA clearances has Neurocept received and when (year)?
Executive summary
Available reporting and the provided sources do not record any FDA approvals, 510(k) clearances, or other formal U.S. regulatory actions explicitly tied to a company or product named “Neurocept.” Most items returned are marketing sites for a dietary supplement called Neurocept (no regulatory filings mentioned) and unrelated FDA action roundups; therefore there is no documented year of FDA clearance or approval for “Neurocept” in the current sources [1] [2] [3].
1. What the sources actually show: supplement marketing, not FDA filings
Multiple provided links are to commercial Neurocept websites that market a dietary nootropic or “brain support” supplement; those pages describe ingredients and claimed benefits but do not report any FDA clearances, approvals, or formal regulatory actions for the product [1] [2] [4]. Independent review pages likewise treat Neurocept as an over‑the‑counter supplement and note that such products are not evaluated by regulators for treating medical conditions [5] [6]. The sources therefore document marketing claims, not FDA authorization.
2. No explicit FDA 510(k) or approval records for “Neurocept” in the provided FDA lists
The provided FDA links include a general 510(k) clearance index and news about approvals and clearances in 2025, but those pages or summaries do not list any item named “Neurocept” among FDA actions in the excerpts given [3] [7]. The available FDA action roundups summarized in the materials discuss other drugs and devices but do not mention a Neurocept clearance or approval [8] [9].
3. Conflicting nomenclature in medical sources increases ambiguity
Some medical/product database or pharmacy‑type pages in the set use “Neurocept” as a drug name or list clinical uses (e.g., as an acetylcholinesterase inhibitor for dementia), but those entries appear to be generic or secondary listings and are not backed here by formal FDA documents or manufacturer regulatory announcements in the provided set [10] [11]. These entries create ambiguity about whether “Neurocept” refers to a marketed supplement brand, a pharmaceutical compound, or a foreign/local trade name; the sources do not reconcile those possibilities [10] [11].
4. How to interpret absence of evidence in these sources
Available sources do not mention any FDA clearance or approval for a Neurocept product; absence from the FDA clearance list excerpt and the lack of regulatory claims on the official marketing pages in this set indicate no documented U.S. regulatory action is shown here [3] [1] [2]. That is not definitive proof that no action exists at all — only that the current reporting and excerpts provided do not include such a record.
5. Alternative explanations and viewpoints present in the sources
One plausible explanation in the materials is that Neurocept, as presented on official pages, is sold as a dietary supplement and therefore would not require FDA clearance or approval like drugs or medical devices; supplements are regulated under different rules and are typically not “cleared” by FDA for efficacy claims [1] [2] [6]. Another possibility suggested by clinical database snippets is that the name “Neurocept” may also be used in other contexts (a pharmaceutical formulation or an international brand), but the current sources do not tie any such use to a U.S. FDA action [10] [11].
6. What a thorough next step would be (based on gaps shown)
To resolve this conclusively, search the FDA’s databases directly (510(k), Premarket Approval, NDI/DSHEA notices for supplements, and Drugs@FDA) and corporate press releases for explicit mention of FDA clearances or approvals for any product named “Neurocept.” The excerpts provided include a general cleared 510(k) list page but do not contain a matching entry for Neurocept in the supplied snippets [3]. The current materials do not include those direct regulatory records.
Limitations and sourcing note: every factual point above is drawn from the supplied search results; if you want, I will query the FDA databases and corporate filings directly (or you can provide additional documents) to attempt to produce definitive dates or clearance numbers.