Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cmt Medical Technologies, Ltd. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
65 daysmedian FDA review time
183 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202235 | ArtPIX DRF | Cmt Medical Technologies, Ltd. | 2020-09-03 | 27 | 0 |
| K162224 | ArtPix Mobile EZ2GO | Cmt Medical Technologies, Ltd. | 2016-09-22 | 45 | 0 |
| K110849 | PRESTODR 4143 | Cmt Medical Technologies, Ltd. | 2011-04-26 | 29 | 0 |
| K103038 | DUET DRF | Cmt Medical Technologies, Ltd. | 2011-03-29 | 166 | 0 |
| K100400 | PRESTODR PORTABLE | Cmt Medical Technologies, Ltd. | 2010-04-22 | 65 | 0 |
| K080890 | SMARTSPOT PRIMAX | Cmt Medical Technologies, Ltd. | 2008-04-29 | 29 | 0 |
| K003438 | SMART RAD | Cmt Medical Technologies, Ltd. | 2001-07-03 | 239 | 0 |
| K001111 | PANORET, MODEL 1000A | Cmt Medical Technologies, Ltd. | 2000-07-07 | 92 | 0 |
| K991578 | SMARTSPOT 2000 | Cmt Medical Technologies, Ltd. | 1999-06-03 | 28 | 0 |
| K961140 | FLUOROPLUS CARDIAC TV | Cmt Medical Technologies, Ltd. | 1996-09-20 | 183 | 0 |
| K961307 | SMART SPOT | Cmt Medical Technologies, Ltd. | 1996-07-01 | 88 | 1 |
| K953950 | FLUORO CATHETER | Cmt Medical Technologies, Ltd. | 1995-09-18 | 27 | 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