Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wuestec Medical, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
881 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993962 | PENSIL TRAUMA, MODEL WWS6100 | Wuestec Medical, Inc. | 1999-12-21 | 57 | 0 |
| K992603 | XRT 600 R/F, WRF 0600 | Wuestec Medical, Inc. | 1999-10-25 | 83 | 0 |
| K992103 | C-QUEST | Wuestec Medical, Inc. | 1999-09-01 | 71 | 0 |
| K981880 | DX-480, ADD ON DIGITAL IMAGER | Wuestec Medical, Inc. | 1998-10-20 | 145 | 0 |
| K974240 | LIGHTLINE-M | Wuestec Medical, Inc. | 1997-12-22 | 40 | 0 |
| K960083 | MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300 | Wuestec Medical, Inc. | 1996-07-24 | 195 | 0 |
| K955414 | XRT 400 | Wuestec Medical, Inc. | 1996-07-24 | 240 | 0 |
| K935123 | SUPERSTAND 300 | Wuestec Medical, Inc. | 1996-03-27 | 881 | 0 |
| K933253 | SUPERSTAND 3000 | Wuestec Medical, Inc. | 1993-08-16 | 45 | 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