Capnia Inc

Foster City, CA, US

CAPNIA, INC. appears in FDA device records in Foster City, CA. FDA records list 4 510(k) clearances between 2012-10-31 and 2026-05-29, no PMA records and one registered establishment. As of 2026-09-10, FDA records show one recall for this company, and at least one establishment registration is current.

510(k) clearances: 4
PMA records: 0
Recall records: 1
Registered establishments: 1

510(k) clearance history

FDA records hold 4 510(k) clearances for Capnia Inc between 2012 and 2026. The busiest year on record is 2012, with 1. The most recent is 2026, with 1.

Clearances by year, as a table

510(k) clearance decisions for Capnia Inc, by decision year
Year	Clearances
2012	1
2014	1
2015	1
2026	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K253119	CoSense ETCO Monitor	CCJ	Substantially Equivalent	2026-05-29
K151107	CoSense ETCO Monitor	CCJ	Substantially Equivalent	2015-07-22
K130036	COSENSE CO MONITOR	CCJ	Substantially Equivalent	2014-01-14
K121768	COSENSE	CCJ	Substantially Equivalent	2012-10-31

Registered establishments

FDA registered establishments for Capnia Inc, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3008614998	3008614998	CAPNIA, INC.	1101 Chess Drive, Foster City, CA 94404 US	2026	CCJ

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

CCJAnalyzer, Gas, Carbon-Monoxide, Gaseous-Phase

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-2198-2025	Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor	Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to insufficient aeration of the cannula's carbon filter prior to sealing, which may lead to higher than expected ETOCc scores during clinical evaluations.	Class II	2025-04-21	Open, Classified

Verification record

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain