Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
KQS · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
51 daysmedian FDA review time
112 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K955019 | UROTRACT I | Dornier Medtech America, Inc. | 1995-12-06 | 34 | 0 |
| K872022 | UROVIEW | Oec-Diasonics, Inc. | 1987-07-16 | 51 | 0 |
| K864846 | RADIOGRAPHIC - LEG SECTION | American Sterilizer Co. | 1986-12-24 | 14 | 0 |
| K860040 | HYDRAJUST III UROLOGICAL TABLE | Mallinckrodt Group, Inc. | 1986-02-10 | 35 | 0 |
| K852127 | AMSCO URO-ENDO MOBILE TABLE | American Sterilizer Co. | 1985-08-08 | 85 | 0 |
| K801723 | UR 150-UR 150T | Siemens Corp. | 1980-08-13 | 20 | 0 |
| K791699 | HYDRADJUST II UROLOGICAL TABLE | Sybron Corp. | 1979-10-22 | 54 | 0 |
| K760522 | TABLE, UROSURGICAL | Mallinckrodt Group, Inc. | 1976-12-16 | 112 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda