FDA product code CBP: Valve, Non-Rebreathing
CBP is the FDA product code for valve, non-rebreathing. It is a Class II device, regulated under 21 CFR 868.5870 and reviewed by the Anesthesiology panel. FDA has cleared 103 510(k) submissions under CBP, 2 in the last five years, from 67 different applicants. The average 510(k) review took 161 days (median 151); 200 days on average over the last three years. FDA has posted 7 recalls for CBP devices.
Classification
| Field | Value |
|---|---|
| Device name | Valve, Non-Rebreathing |
| Device class | Class II |
| Regulation | 21 CFR 868.5870 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for CBP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 140 |
| 2019 | 1 | 480 |
| 2020 | 1 | 461 |
| 2021 | 1 | 265 |
| 2024 | 2 | 200 |
Compare with all 510(k) review times · Search every CBP clearance
Top CBP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Instrumentation Industries, Inc. | 7 | 1999-07-01 |
| Rondex Products, Inc. | 6 | 1998-05-19 |
| Plasco, Inc. | 5 | 1996-03-20 |
| Protectaide, Inc. | 4 | 1994-10-31 |
| Mem Medical, Inc. | 4 | 1979-10-09 |
62 more applicants have CBP clearances. See the full list in Caduvo.
Most recent CBP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241366 | Dehas Medical Systems GmbH | QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV) | 2024-10-29 | 168 |
| K234053 | Fisher & Paykel Healthcare, Ltd. | F&P Optiflow Flow Diverter | 2024-08-09 | 231 |
| K210992 | Meditera Tibbi Malzeme San VE Tic AS | Altech® Exhalation Valve (Single Limb and Dual Limb) | 2021-12-23 | 265 |
| K192285 | Firstar Healthcare Company Limited (Guangzhou) | CPR Face Shield | 2020-11-25 | 461 |
| K173770 | Fisher & Paykel Healthcare Limited | OJR215 Pressure Relief Manifold | 2019-04-05 | 480 |
Recalls for CBP devices
7 product recalls in 3 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-05-16.
Frequently asked questions
What is FDA product code CBP?
CBP is the FDA product code for valve, non-rebreathing. It is a Class II device, regulated under 21 CFR 868.5870 and reviewed by the Anesthesiology panel.
What device class is CBP?
Class II, regulation 21 CFR 868.5870. Typical premarket route: 510(k).
How long does a 510(k) take for product code CBP?
Across 103 cleared submissions the average was 161 days from receipt to decision (median 151).
Which companies have the most CBP clearances?
Instrumentation Industries, Inc. (7); Rondex Products, Inc. (6); Plasco, Inc. (5); Protectaide, Inc. (4); Mem Medical, Inc. (4).
Have CBP devices been recalled?
Yes: 7 product recalls across 3 recall events; the most recent began 2016-05-16.
Next steps
- Run an FDA pathway report with predicate devices for product code CBP
- Run a recall and safety report across every CBP manufacturer
- Watch product code CBP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Anesthesiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times