Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kingston Technologies, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
161 daysmedian FDA review time
261 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K935232 | HYDROTORQUE GUIDE WIRE | Kingston Technologies, Inc. | 1994-07-20 | 261 | 0 |
| K940814 | HYDRO-M(TM) WOUND GEL | Kingston Technologies, Inc. | 1994-05-12 | 79 | 0 |
| K940738 | KTI HY-Q(TM) WOUND DRESSING | Kingston Technologies, Inc. | 1994-05-06 | 78 | 0 |
| K925660 | KTI TRANSPARENT WOUND DRESSING | Kingston Technologies, Inc. | 1993-04-20 | 161 | 0 |
| K921502 | HYSORB WOUND DRESSING | Kingston Technologies, Inc. | 1992-09-29 | 182 | 0 |
| K882157 | PANAMEX(TM) URETERAL STENT | Kingston Technologies, Inc. | 1988-08-02 | 71 | 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