Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medx, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
156 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K082581 | C-QUEST | Medx, Inc. | 2008-11-14 | 70 | 0 |
| K073456 | T-QUEST SYSTEM | Medx, Inc. | 2007-12-20 | 10 | 0 |
| K041840 | MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM | Medx, Inc. | 2004-08-20 | 43 | 0 |
| K012953 | GIOTTO IMAGE | Medx, Inc. | 2001-11-30 | 87 | 0 |
| K993893 | MEDX INTECAM INTERFACE | Medx, Inc. | 2000-02-10 | 86 | 0 |
| K884661 | D-SCOPE III | Medx, Inc. | 1989-04-12 | 156 | 0 |
| K872127 | D-SCOPE II AND D-SCOPE IIC | Medx, Inc. | 1987-06-18 | 16 | 0 |
| K870703 | SKAN D-SCOPE | Medx, Inc. | 1987-02-26 | 6 | 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