FOB
5 FDA 510(k) clearances · Product code
22 daysmedian time to decision
81 days90th percentile
5clearances measured
FDA profile
- Official device name
- Bedpan
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6730
- Medical specialty
- General Hospital
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2003: 2
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 |
|---|---|---|
| DISPOSABLE BEDPAN (K791346) | General Clinical Plastics Corp. | 1979-08-03 |
| STAND UP TOILET (K780370) | Medical Specialty Products, Inc. | 1978-04-10 |
| BEDPAN, GENERAL MEDICAL MEDI-PAK (K760490) | Landmark Plastics | 1976-11-12 |
| BED PAN, STACKABLE (AUTOCLAVABLE) (K760393) | Bemis Health Care | 1976-08-23 |
| BEDPAN, SINGLE PATIENT USE, TECNOL (K760307) | Tecnol New Jersey Wound Care, Inc. | 1976-08-11 |
Track FOB automatically
Every clearance here is in the API, with alerts when new ones post.