KQS
8 FDA 510(k) clearances · Product code
51 daysmedian time to decision
112 days90th percentile
8clearances measured
FDA profile
- Official device name
- Table, Cystometric, Non-Electric And Accessories
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.4890
- Medical specialty
- Gastroenterology, Urology
- Adverse events (MAUDE)
- 2007: 2 · 2008: 138 · 2009: 178 · 2010: 106 · 2011: 172 · 2012: 21
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 |
|---|---|---|
| UROTRACT I (K955019) | Dornier Medtech America, Inc. | 1995-12-06 |
| UROVIEW (K872022) | Oec-Diasonics, Inc. | 1987-07-16 |
| RADIOGRAPHIC - LEG SECTION (K864846) | American Sterilizer Co. | 1986-12-24 |
| HYDRAJUST III UROLOGICAL TABLE (K860040) | Mallinckrodt Group, Inc. | 1986-02-10 |
| AMSCO URO-ENDO MOBILE TABLE (K852127) | American Sterilizer Co. | 1985-08-08 |
| UR 150-UR 150T (K801723) | Siemens Corp. | 1980-08-13 |
| HYDRADJUST II UROLOGICAL TABLE (K791699) | Sybron Corp. | 1979-10-22 |
| TABLE, UROSURGICAL (K760522) | Mallinckrodt Group, Inc. | 1976-12-16 |
Track KQS automatically
Every clearance here is in the API, with alerts when new ones post.