Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Contec Medical System Co., Ltd. · Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
181 daysmedian FDA review time
377 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180837 | CONTEC Oxygen Concentrator | Contec Medical System Co., Ltd. | 2019-01-10 | 286 | 0 |
| K131900 | CONTEC ELECTROCARDIOGRAPH | Contec Medical System Co., Ltd. | 2014-03-05 | 253 | 0 |
| K101273 | DYNAMIC ECG SYSTEM MODEL TLC5000 | Contec Medical System Co., Ltd. | 2011-09-30 | 512 | 0 |
| K110156 | AMBULATORY BLLOD PRESSURE MONITOR, ELECTRONIC SPHYGMOMANOMET | Contec Medical System Co., Ltd. | 2011-07-27 | 189 | 0 |
| K101692 | PATIENT MONITOR | Contec Medical System Co., Ltd. | 2011-06-28 | 377 | 1 |
| K110774 | ELECTRONIC SPHYGMOMANOMETER | Contec Medical System Co., Ltd. | 2011-05-13 | 53 | 0 |
| K101127 | PATIENT MONITOR, MODEL PM50 | Contec Medical System Co., Ltd. | 2010-06-11 | 50 | 0 |
| K090936 | SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A | Contec Medical System Co., Ltd. | 2009-08-25 | 145 | 0 |
| K090671 | PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D | Contec Medical System Co., Ltd. | 2009-06-11 | 90 | 0 |
| K082480 | CONTEC POCKET FETAL DOPPLER | Contec Medical System Co., Ltd. | 2009-02-25 | 181 | 0 |
| K082641 | FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL | Contec Medical System Co., Ltd. | 2008-11-10 | 60 | 0 |
| K073454 | FINGERTIP PULSE OXIMETER, MODEL CMS-50C | Contec Medical System Co., Ltd. | 2008-05-05 | 147 | 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