KMO
5 FDA 510(k) clearances · Product code
98 daysmedian time to decision
539 days90th percentile
5clearances measured
FDA profile
- Official device name
- Binder, Elastic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5160
- Medical specialty
- General Hospital
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2000: 1
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 |
|---|---|---|
| 4 SURE TM RECTAL TUBE (K921852) | Boston Pacific Medical, Inc. | 1993-10-08 |
| COUGH PILLOW (K893809) | Custom Hospitals Products | 1989-08-28 |
| THORACIC SUPPORT SYSTEM (K883214) | Storer Medical Products | 1989-01-17 |
| HEART HUGGER STERNUM SUPPORT HARNESS (K882592) | General Cardiac Technology, Inc. | 1988-09-20 |
| STERILIZATION PROCESS/T-BINDER (K792629) | Procter & Gamble Mfg. Co. | 1980-01-11 |
Track KMO automatically
Every clearance here is in the API, with alerts when new ones post.