FDA product code BZB: Catheter, Nasal, Oxygen
BZB is the FDA product code for catheter, nasal, oxygen. It is a Class I device, regulated under 21 CFR 868.5350 and reviewed by the Anesthesiology panel. FDA has cleared 8 510(k) submissions under BZB, from 8 different applicants. The average 510(k) review took 69 days (median 58). FDA has posted 1 recall for BZB devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Nasal, Oxygen |
| Device class | Class I |
| Regulation | 21 CFR 868.5350 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BZB clearance
Top BZB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Unoplast A/S | 1 | 1990-03-30 |
| Zimmar Consulting , Ltd. | 1 | 1984-11-19 |
| Healthdyne, Inc. | 1 | 1984-03-19 |
| Medovations, Inc. | 1 | 1983-05-18 |
| American Pharmaseal Div. Ahsc | 1 | 1982-04-16 |
3 more applicants have BZB clearances. See the full list in Caduvo.
Most recent BZB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K896731 | Unoplast A/S | OXYGEN CATHETERS | 1990-03-30 | 120 |
| K843466 | Zimmar Consulting , Ltd. | PHARMA-PLAST OXYGEN CATHETER | 1984-11-19 | 74 |
| K833351 | Healthdyne, Inc. | DEMAND OXYGEN CONTROLLER | 1984-03-19 | 173 |
| K830984 | Medovations, Inc. | OXYGEN CATHETERS | 1983-05-18 | 50 |
| K820370 | American Pharmaseal Div. Ahsc | NASAL OXYGEN CATHETER | 1982-04-16 | 66 |
Recalls for BZB devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-11-27.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code BZB?
BZB is the FDA product code for catheter, nasal, oxygen. It is a Class I device, regulated under 21 CFR 868.5350 and reviewed by the Anesthesiology panel.
What device class is BZB?
Class I, regulation 21 CFR 868.5350. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BZB?
Across 8 cleared submissions the average was 69 days from receipt to decision (median 58).
Which companies have the most BZB clearances?
Unoplast A/S (1); Zimmar Consulting , Ltd. (1); Healthdyne, Inc. (1); Medovations, Inc. (1); American Pharmaseal Div. Ahsc (1).
Have BZB devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-11-27.
Next steps
- Run an FDA pathway report with predicate devices for product code BZB
- Run a recall and safety report across every BZB manufacturer
- Watch product code BZB 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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