Capnia Inc

FDA Regulatory Profile

Capnia Inc appears in FDA public data with 1 recall, 4 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2198-2025, Class II) was initiated on April 21, 2025. Its most recent 510(k) clearance was granted on May 29, 2026.

Summary

Total Recalls
1
510(k) Clearances
4
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2198-2025Class IIPrecision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide MonitorApril 21, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K253119CoSense ETCO MonitorMay 29, 2026
K151107CoSense ETCO MonitorJuly 22, 2015
K130036COSENSE CO MONITORJanuary 14, 2014
K121768COSENSEOctober 31, 2012