Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lumex, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
149 daysmedian FDA review time
203 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K963674 | LUMEX AIR | Lumex, Inc. | 1997-01-10 | 119 | 0 |
| K962123 | AKROTECH 4000T KINETIC TURNING LOW AIR LOSS SYSTEM | Lumex, Inc. | 1996-07-18 | 48 | 0 |
| K953675 | ALTADYNE | Lumex, Inc. | 1995-09-28 | 52 | 0 |
| K945175 | MECHANICAL WHEELCHAIR 890.3850 | Lumex, Inc. | 1995-05-12 | 203 | 0 |
| K945257 | 577ES (ERGOSENSE) | Lumex, Inc. | 1995-04-26 | 180 | 0 |
| K944574 | LUMEX WHEELCHAIRS (SER. 1000, 3000, 4000, 5000, TILT-IN-SPAC | Lumex, Inc. | 1994-10-17 | 28 | 0 |
| K923977 | AKROTECH 4000 | Lumex, Inc. | 1993-02-12 | 189 | 0 |
| K895740 | SHOWER CHAIRS;BED/STRETCHER;LINEN & UTILITY CART | Lumex, Inc. | 1990-02-22 | 149 | 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