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Sleep Analysis Module (K261521): 510(k) cleared for Neurotronics, LLC vs FAQ™ (FAQ 411) (K261565): 510(k) cleared for Foreo, Inc.: FDAPulse comparison

FAQ™ (FAQ 411) (K261565): 510(k) cleared for Foreo, Inc.'s review days of 164 is 1.1x Sleep Analysis Module (K261521): 510(k) cleared for Neurotronics, LLC's 155 (59th percentile). Sleep Analysis Module (K261521): 510(k) cleared for Neurotronics, LLC is dated 2026-10-09; FAQ™ (FAQ 411) (K261565): 510(k) cleared for Foreo, Inc. 2026-10-22.

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

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How does Sleep Analysis Module (K261521): 510(k) cleared for Neurotronics, LLC compare to FAQ™ (FAQ 411) (K261565): 510(k) cleared for Foreo, Inc.?

FieldSleep Analysis Module (K261521): 510(k) cleared for Neurotronics, LLCFAQ™ (FAQ 411) (K261565): 510(k) cleared for Foreo, Inc.
Record510(k) clearance510(k) clearance
510(k) numberK261521K261565
DeviceSleep Analysis ModuleFAQ™ (FAQ 411)
ApplicantNeurotronics, LLCForeo, Inc.
Specialty / panelNeurologyNeurology
Product codeOLZNFO
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2026-05-072026-05-11
Decision date2026-10-092026-10-22
Review time (days)155164
Third-party reviewNoNo
Applicant locationAlachua, FL, USLas Vegas, NV, US
amount percentile58th59th
Predicate Speed & CAPA Advisory Opportunity Score48/10054/100
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Official records: Sleep Analysis Module (K261521): 510(k) cleared for Neurotronics, LLC · FAQ™ (FAQ 411) (K261565): 510(k) cleared for Foreo, Inc.

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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

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