FDA applicant
Capnia, Inc.
FDA records 4 decisions for Capnia, Inc. (Palo Alto, CA) from 2012 to 2026: 4 510(k) clearances. All are in product code CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase). Its devices cite 4 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Capnia, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2015
2012high 1 (2012) · low 0 (2013)2026
2026 so far, outlined.
Recalls per year
1in 2025
2012high 1 (2025) · low 0 (2012)2026
Class I Class II/III not classified
Planning a device like Capnia, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report