Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Imex Medical Systems, Inc. · Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
154 daysmedian FDA review time
262 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973556 | IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000 | Imex Medical Systems, Inc. | 1998-04-24 | 217 | 0 |
| K973562 | IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100 | Imex Medical Systems, Inc. | 1998-04-15 | 208 | 0 |
| K973336 | IMEX STETHODOP | Imex Medical Systems, Inc. | 1998-02-05 | 154 | 0 |
| K970156 | IMEX FUTURALDOP PRO | Imex Medical Systems, Inc. | 1997-04-04 | 78 | 0 |
| K942243 | IMEX 8000 PERSONAL CASCULAR LAB | Imex Medical Systems, Inc. | 1995-11-03 | 543 | 0 |
| K944196 | IMWXDOP IR | Imex Medical Systems, Inc. | 1995-05-12 | 256 | 0 |
| K942441 | IMEXDOP CT+ | Imex Medical Systems, Inc. | 1994-08-23 | 92 | 0 |
| K910462 | POCKET DOP 3 | Imex Medical Systems, Inc. | 1991-06-24 | 140 | 0 |
| K901593 | IMEX DOP-TONE II | Imex Medical Systems, Inc. | 1990-07-02 | 88 | 0 |
| K896613 | FLAT VASCULAR PROBE | Imex Medical Systems, Inc. | 1990-02-16 | 87 | 0 |
| K882138 | IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER | Imex Medical Systems, Inc. | 1988-11-07 | 171 | 0 |
| K874726 | MASCOT STETHOSCOPE PROBE | Imex Medical Systems, Inc. | 1988-03-31 | 134 | 0 |
| K871212 | MASCOT CW DOPPLER SYSTEM | Imex Medical Systems, Inc. | 1987-08-14 | 141 | 0 |
| K863702 | PULSE CUFF RECORDER MODEL PCR100 | Imex Medical Systems, Inc. | 1987-06-12 | 262 | 0 |
| K851269 | DOPLETTE 10 | Imex Medical Systems, Inc. | 1985-07-29 | 187 | 0 |
| K840285 | NON STRESS TEST MONITOR 507 | Imex Medical Systems, Inc. | 1984-05-09 | 106 | 0 |
| K834284 | ULTRASOUND SCANNER 501 | Imex Medical Systems, Inc. | 1984-05-09 | 166 | 0 |
| K832369 | VASCULAR RECORDER #301 | Imex Medical Systems, Inc. | 1984-03-12 | 241 | 0 |
| K832696 | RISER STANDUP WHEELCHAIR | Imex Medical Systems, Inc. | 1983-09-20 | 41 | 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