510(k) Report

FDA applicant

Capnia, Inc.

Palo Alto, CA4 decisions2012–20261 recall

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, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Capnia, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2012: 12014: 12015: 12026 (partial year): 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2025

2025: 1
2012high 1 (2025) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Capnia, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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