CoSense Precision Sampling Set

United States

Model C20206 · Capnia, INC.

The Precision Sampling Set is a single use microfluidic sampling set (nasal cannula). To ensure a valid sampling set is used, when the Precision Sampling Set is connected to the Monitor, there is an electronic handshake between it and the CoSense Monitor. Note: The CoSense Monitor is a reusable electrical medical device with integrated software used in conjunction with a precision sampling set to collect a breath sample from the patient and measure the end tidal carbon monoxide in exhaled breath. The device is non-sterile. No reprocessing is required between uses.

DI: 00858481006055
Device class: Class II
Product codes
Submissions: K121768
K130036
K151107
Other identifiers: 00858481006062package
00858481006079package

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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

Initiated	Recall #	Class	Status	Reason	Quantity	Link basis
2025-04-21	Z-2198-2025	Class II	Open, Classified	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.Distribution: US Nationwide distribution in the states of PA, UT, TX, FL, MA, IA.	2160	clearance family

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

K121768
- K080278

Cited as predicate by: K130036

K130036
- K121768
  - K080278
- K974805

Cited as predicate by: K151107

K151107
- K130036
  - K121768
    - K080278
  - K974805

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

Date	Type	Outcome	Facility
2026-05-07	VAI	Voluntary action indicated	Capnia, Inc.
2026-05-07	VAI	Voluntary action indicated	Capnia, Inc.
2018-03-23	NAI	No action indicated	Capnia, Inc.
2018-03-23	NAI	No action indicated	Capnia, Inc.
2014-07-29	NAI	No action indicated	Capnia, Inc.
2014-07-29	NAI	No action indicated	Capnia, Inc.

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