BZB
8 FDA 510(k) clearances · Product code
66 daysmedian time to decision
173 days90th percentile
8clearances measured
FDA profile
- Official device name
- Catheter, Nasal, Oxygen
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5350
- Medical specialty
- Anesthesiology
- Adverse events (MAUDE)
- 2005: 1 · 2014: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| OXYGEN CATHETERS (K896731) | Unoplast A/S | 1990-03-30 |
| PHARMA-PLAST OXYGEN CATHETER (K843466) | Zimmar Consulting , Ltd. | 1984-11-19 |
| DEMAND OXYGEN CONTROLLER (K833351) | Healthdyne, Inc. | 1984-03-19 |
| OXYGEN CATHETERS (K830984) | Medovations, Inc. | 1983-05-18 |
| NASAL OXYGEN CATHETER (K820370) | American Pharmaseal Div. Ahsc | 1982-04-16 |
| OXYGEN CATHETER (K800506) | Medi-Craft , Ltd. | 1980-03-25 |
| CONPHAR OXYGEN CATHETER-STERILE (K791273) | Conphar, Inc. | 1979-07-24 |
| CATHETER, OXYGEN (K790057) | Medline Industries, Inc. | 1979-02-05 |
Track BZB automatically
Every clearance here is in the API, with alerts when new ones post.