Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EXQ — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
178 daysmedian FDA review time
376 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253537 | Glean Urodynamics System Male Delivery System (GUS-1000-M); | Bright Uro, Inc. | 2026-04-16 | 154 | 0 |
| K243052 | Glean Urodynamics System Male Delivery System (GUS-1000-M); | Bright Uro, Inc. | 2025-03-24 | 178 | 0 |
| K931282 | VOLUME TRANSDUCER | Life-Tech Intl., Inc. | 1993-09-17 | 189 | 0 |
| K931574 | ADVANCE MODEL UDS-ADV | Laborie Medical Technologies, Ltd. | 1993-08-05 | 128 | 0 |
| K920574 | CAMSYS 6300 | F.M. Wiest USA, Inc. | 1993-02-17 | 376 | 0 |
| K880391 | DACOMED CYSTOMETER | Dacomed Corp. | 1988-04-27 | 89 | 0 |
| K812177 | LIFE-TECH #1857 PRESSURE/POLOT MODULE | Life-Tech Instruments, Inc. | 1981-09-09 | 37 | 0 |
| K781032 | AQUA-GEL | Murray, Salk, Inc. | 1978-12-15 | 179 | 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