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Which Neurocept products (by name) have FDA clearance, and what are their intended uses as of 2025?
Executive Summary
As of 2025 there is no evidence that any product marketed under the “Neurocept” consumer supplement brand holds FDA clearance or approval; the websites and reviews labeled “Neurocept” describe dietary supplements and capsules without citing FDA device or drug clearances [1] [2] [3]. A separate product with a similar name — the Neuroguard IEP System by Contego Medical Inc. — received FDA clearance in October 2024 for carotid artery re-opening using an integrated embolic protection system; this is not a Neurocept consumer product but a cleared medical device with a distinct manufacturer and intended use [4].
1. Why the name confusion matters and what the record shows
Public materials for products called “Neurocept” operate as dietary supplement marketing and do not appear in FDA device or drug clearance databases. Company websites and consumer-review pages identified in 2025 describe ingredient lists, brain-health claims, and capsule formats consistent with over-the-counter supplements, and none of these pages cite 510(k) clearances, PMA approvals, or NDAs from the FDA [1] [2] [3]. Regulatory channels for drugs and devices require public filings and FDA summaries; searches summarized in the provided analyses turned up no such filings tied to a “Neurocept” supplement brand. This absence of federal clearance is a crucial regulatory distinction because supplements are not FDA-cleared to treat disease, while cleared medical devices and approved drugs carry explicit intended-use language and regulatory documentation [1] [3].
2. The one FDA-cleared product with a similar name and its explicit intent
A product with a similar prefix, the Neuroguard IEP System, received FDA clearance (P240009) on October 11, 2024, with a clearly stated intended use to re-open partly blocked carotid arteries and provide embolic protection during stent placement, using a self-expanding stent, delivery catheter, post-dilatation balloon, and integrated embolic protection components [4]. This clearance is tied to Contego Medical Inc., not to the consumer supplement marketed as “Neurocept.” Regulatory documentation for Neuroguard lists device components and a vascular indication, which is a far different regulatory category and clinical purpose than brain-health supplements marketed online [4]. Confusing these names can mislead consumers into thinking a supplement has the clinical validation and clearance that the Neuroguard device legally possesses.
3. Claims about Neurocept Pg Capsule 10 and the drug-angle that did not pan out
Some online pharmacy or drug-info entries discuss a product named Neurocept Pg Capsule 10 and describe its use for nerve pain associated with diabetes and shingles, implying an active ingredient similar to pregabalin. The analyses indicate these listings do not demonstrate FDA clearance for that branded capsule, and they rely on therapeutic descriptions consistent with prescription gabapentinoids rather than OTC supplements [5]. No official FDA approval or clearance record for a prescription product explicitly named “Neurocept Pg Capsule 10” was found in the provided materials, so any therapeutic claims on retail listings should be treated as product-specific listings rather than evidence of regulatory approval [5].
4. Red flags from promotional sites and enforcement history that readers should weigh
Multiple sources flagged the supplement-marketing pages for unsubstantiated claims and aggressive advertising, and one of the included analyses referenced FDA warning letters historically directed at companies selling unapproved Alzheimer’s products; those enforcement examples underscore how supplement or device claims can trigger regulatory action when they cross into disease treatment claims [6]. The consumer-facing Neurocept pages emphasize ingredients and memory-boosting narratives without pointing to clinical trials or FDA summaries. Promotion-driven content often aims to sell rather than to document regulatory status; the absence of an FDA clearance citation on these pages is itself a meaningful indicator [1] [2] [7].
5. Bottom line and what to watch next for verification
Based on the provided analyses and date-stamped source summaries through 2025, no Neurocept-branded supplement or capsule is FDA cleared or approved for medical indications, while the similarly named Neuroguard IEP System is a cleared medical device for carotid artery intervention issued in October 2024 [1] [4]. Consumers and clinicians should verify product regulatory status by checking the FDA’s 510(k)/PMA/Drug Approval databases and scrutinizing manufacturer names — manufacturer identity matters because the Neuroguard clearance belongs to Contego Medical, not to any Neurocept supplement vendor [4] [1]. If you want, I can run targeted searches of the FDA device and drug databases and extract the specific clearance documents or absence notices for each Neurocept variant you care about.