FDA product code CBN: Apparatus, Gas-Scavenging
CBN is the FDA product code for apparatus, gas-scavenging. It is a Class II device, regulated under 21 CFR 868.5430 and reviewed by the Anesthesiology panel. FDA has cleared 43 510(k) submissions under CBN, 1 in the last five years, from 34 different applicants. The average 510(k) review took 142 days (median 87). FDA has posted 5 recalls for CBN devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Gas-Scavenging |
| Device class | Class II |
| Regulation | 21 CFR 868.5430 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for CBN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 395 |
| 2020 | 1 | 340 |
| 2023 | 1 | 110 |
Compare with all 510(k) review times · Search every CBN clearance
Top CBN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Teleflexmedical, Inc. | 3 | 2014-10-30 |
| G. Dundas Co.,Inc. | 2 | 2011-06-23 |
| Accutron, Inc. | 2 | 2004-03-12 |
| Porter Instrument Co., Inc. | 2 | 1998-06-16 |
| Technical Medical Products, Inc. | 2 | 1990-01-22 |
29 more applicants have CBN clearances. See the full list in Caduvo.
Most recent CBN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K223452 | Parker Hannifin Corporation | Nitronox Scavenger Plus | 2023-03-05 | 110 |
| K193646 | Anesthetic Gas Reclamation, Inc. | Dynamic Gas Scavenging System 2 (DGSS - 2) | 2020-12-04 | 340 |
| K160950 | Sedation Systems, LLC | MINISCAV | 2017-05-05 | 395 |
| K142138 | Teleflexmedical, Inc. | ISO-GARD MASK | 2014-10-30 | 86 |
| K132729 | Teleflexmedical, Inc. | ISO-GARD MASK | 2014-01-09 | 128 |
Recalls for CBN devices
5 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-05-09.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code CBN?
CBN is the FDA product code for apparatus, gas-scavenging. It is a Class II device, regulated under 21 CFR 868.5430 and reviewed by the Anesthesiology panel.
What device class is CBN?
Class II, regulation 21 CFR 868.5430. Typical premarket route: 510(k).
How long does a 510(k) take for product code CBN?
Across 43 cleared submissions the average was 142 days from receipt to decision (median 87).
Which companies have the most CBN clearances?
Teleflexmedical, Inc. (3); G. Dundas Co.,Inc. (2); Accutron, Inc. (2); Porter Instrument Co., Inc. (2); Technical Medical Products, Inc. (2).
Have CBN devices been recalled?
Yes: 5 product recalls across 3 recall events; the most recent began 2022-05-09.
Next steps
- Run an FDA pathway report with predicate devices for product code CBN
- Run a recall and safety report across every CBN manufacturer
- Watch product code CBN 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.
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