Facility

CAPNIA, INC.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3008614998
Establishment type	Manufacture Medical Device
Location	1101 Chess Drive Foster City, CA, US 94404
Registration status	Active · expires 2026
Parent company	Capnia, Inc. (owner-operator 10042955)
Brand names	CoSense ETCO Monitor

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Product code CCJ (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.1430

Recalls & enforcement

Class IIOngoing2025-04-21
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…

FDA inspections (2)

NAI2026-05-07
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2018-03-23
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Capnia, Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “CAPNIA, INC. (FEI 3008614998) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008614998-capnia-inc/

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