KTC
7 FDA 510(k) clearances · Product code
23 daysmedian time to decision
104 days90th percentile
7clearances measured
FDA profile
- Official device name
- Bath, Sitz, Nonpowered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5125
- Medical specialty
- Physical Medicine
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2015: 76 · 2016: 19
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 |
|---|---|---|
| THE SPRITZ BATH (K912179) | The Spritz Co. | 1991-08-28 |
| SIT-N-BATHE SITZ BATH (K890085) | Drummond Industries, Inc. | 1989-02-13 |
| SITZ BATH (K862600) | W. C. Green, D.D.S. | 1986-07-18 |
| ABCO PLASTIC UTENSILS (K851309) | Abco Dealers, Inc. | 1985-07-01 |
| MAC LEE SITZ BATH (K841711) | Mac Lee Medical Products | 1984-05-07 |
| SITZ BATH, SINGLE PATIENT USE #8100 (K831762) | Lsl Industries, Inc. | 1983-06-24 |
| PERSONAL SITZ BATH KIT (K800958) | The Healthcare Group Laboratories, Inc. | 1980-05-02 |
Track KTC automatically
Every clearance here is in the API, with alerts when new ones post.