CCN
9 FDA 510(k) clearances · Product code
75 daysmedian time to decision
211 days90th percentile
9clearances measured
FDA profile
- Official device name
- Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.2300
- Medical specialty
- Anesthesiology
- Adverse events (MAUDE)
- 2000: 2 · 2001: 1 · 2003: 3 · 2004: 1 · 2005: 2 · 2020: 29
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 |
|---|---|---|
| FLOWMETER NIPPLE ADAPTOR (K934945) | Cardio-Search , Ltd. | 1993-11-17 |
| OXYGEN FLOW CONTROLLER (K920783) | Puritan Bennett Corp. | 1992-09-18 |
| NEB-U-VENT (K872038) | Design Technologies, Inc. | 1987-08-10 |
| MODIFIED NOFLO I (K871262) | Design Technologies, Inc. | 1987-07-21 |
| NO-FLO I (K863613) | Design Technologies, Inc. | 1986-12-15 |
| OXYGEN CONSERVATOR (K863657) | Salter Labs | 1986-10-15 |
| FLOW INTERRUPTION INDICATOR (K863659) | Salter Labs | 1986-10-15 |
| BORDON GAGE REGULATOR #BG (K823775) | Timeter Instrument Corp. | 1983-01-14 |
| VITAMIN B12 FOLATE RADIOASSAY (K802037) | Corning Medical & Scientific | 1980-11-21 |
Track CCN automatically
Every clearance here is in the API, with alerts when new ones post.