Capnostat 5
by Respironics Novametrix, LLC
510(k) K042601
Capnostat 5 is a medical device (FDA Class II; FDA product code CCK, Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase) made by Respironics Novametrix, LLC, cleared under FDA 510(k) K042601 on 19 Nov 2004, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK042601 | Date19 Nov 2004 | StatusActive |
Official records
- FDA 510(k) database K042601
Recalls
-
- Terminated Z-1261-2010
Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may crack and fail at/or inside the plug. Potential for burns or electrical shock.
Timeline
- Cleared FDA 510(k) K042601
- Recall initiated FDA recalls Z-1261-2010
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- CCK
- FDA applicant
- Respironics Novametrix, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 868.1400
- Advisory committee
- Anesthesiology
- FDA decision
- SESE Substantially Equivalent
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