Skip to content
Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2025-04-21Z-2198-2025Class IIOpen, ClassifiedSampling 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.Distribution: US Nationwide distribution in the states of PA, UT, TX, FL, MA, IA.2160code info di
Regulatory clearances
  • 510(k)K151107Substantially equivalent (SESE) · 2015-07-22clearance family
  • 510(k)K130036Substantially equivalent (SESE) · 2014-01-14clearance family
  • 510(k)K121768Substantially equivalent (SESE) · 2012-10-31clearance family

Predicate lineage

Cited as predicate by: K130036

Cited as predicate by: K151107

Cited as predicate by: K253119

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2026-05-07VAIVoluntary action indicatedCapnia, Inc.0
2026-05-07VAIVoluntary action indicatedCapnia, Inc.0
2018-03-23NAINo action indicatedCapnia, Inc.0
2018-03-23NAINo action indicatedCapnia, Inc.0
2014-07-29NAINo action indicatedCapnia, Inc.0
2014-07-29NAINo action indicatedCapnia, Inc.0
Similar devices
Select up to two to place side-by-side with this device.