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CoSense Precision Sampling Set C20206

by Capnia, Inc.

CoSense Precision Sampling Set C20206 is a Class II device made by Capnia, Inc., cleared under FDA 510(k) K151107 on 22 Jul 2015 (2 earlier submissions) and listed in FDA GUDID since 6 May 2026 (UDI-DI 00858481006055), active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00858481006055 UDI-DI Date6 May 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK151107 Date22 Jul 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151107 decided 22 Jul 2015 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00858481006055 listed 6 May 2026 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2198-2025 FDA Class II initiated 21 Apr 2025

    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.

Timeline

5 dated events

  1. Cleared FDA 510(k) K121768
  2. Cleared FDA 510(k) K130036
  3. Cleared FDA 510(k) K151107
  4. Recall initiated FDA recalls Z-2198-2025
  5. Listed FDA GUDID 00858481006055

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CoSense Precision Sampling Set
Generic name
Carbon monoxide breath analyser
Model / reference
C20206
Primary DI / UDI-DI
00858481006055
510(k) Number
FDA product code
CCJ
GMDN term
Carbon monoxide breath analyser
Device class
Class II
Regulation number
868.1430
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K121768)

Cleared under the same submission (K130036)

Similar devices

Other devices filed under FDA product code CCJ (Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase).

Other devices from Capnia, Inc.

See all devices from Capnia, Inc. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)