BXY
7 FDA 510(k) clearances · Product code
29 daysmedian time to decision
87 days90th percentile
7clearances measured
FDA profile
- Official device name
- Flowmeter, Calibration, Gas
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.2350
- Medical specialty
- Anesthesiology
- Adverse events (MAUDE)
- 1992: 1 · 1999: 2 · 2000: 1 · 2001: 2 · 2004: 2 · 2005: 3
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 |
|---|---|---|
| WESTMED RESPIRATORY LUER ADAPTOR (K953506) | Westmed Intl. | 1995-09-15 |
| PRECISION MEDICAL NEB BLOCK (K902916) | Precision Medical, Inc. | 1990-07-23 |
| PRECISION MEDICAL ELIMINATOR (K902917) | Precision Medical, Inc. | 1990-07-23 |
| OXY-OFF(TM) (K863510) | B&B Medical Technologies, Inc. | 1986-10-22 |
| LSP MINILATOR (K860516) | Life Support Products, Inc. | 1986-02-21 |
| NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA (K851460) | Telectronics, Inc. | 1985-05-10 |
| PFT GASES (K781523) | Gardner Cryogenics | 1978-12-01 |
Track BXY automatically
Every clearance here is in the API, with alerts when new ones post.