Data / Medical devices / United States / Capnia, Inc.
Capnia, Inc.: FDA-registered device maker in Foster City, CA, United States, 3 510(k) clearances
Capnia, Inc. is registered with the FDA (registration 3008614998) in Foster City, CA, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated July 22, 2015. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008614998
- Address
- 1101 Chess Drive, Foster City, CA, United States, 94404
- Owner or operator
- Capnia, Inc. (10042955)
- Roles
- Manufacturer
- First device listed
- January 14, 2013
- Registered through
- 2026
- Brand names listed
- CoSense CO Monitor, CoSense ETCO Monitor, CoSense End Tidal Carbon Monoxide Monitor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase | CCJ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 22, 2015 | K151107 | CoSense ETCO Monitor | CCJ | Substantially Equivalent | Capnia, Inc. | accessdata.fda.gov |
| January 14, 2014 | K130036 | COSENSE CO MONITOR | CCJ | Substantially Equivalent | Capnia, Inc. | accessdata.fda.gov |
| October 31, 2012 | K121768 | COSENSE | CCJ | Substantially Equivalent | Capnia, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 21, 2025 | 97184 | Class II | Ongoing | 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. | accessdata.fda.gov |
Compare with other makers
Updated July 29, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.