Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Conmed Andover Medical, Inc. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
105 daysmedian FDA review time
203 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K945836 | 1800 MONITORING ECG ELECTRODE AND 1870 DIAPHORETIC MONITORIN | Conmed Andover Medical, Inc. | 1995-06-20 | 203 | 0 |
| K946273 | 1700 MONITORING ECG ELECTRODE | Conmed Andover Medical, Inc. | 1995-05-17 | 146 | 0 |
| K944655 | ECG ELECTRODE | Conmed Andover Medical, Inc. | 1994-11-22 | 62 | 0 |
| K944726 | 1710 MONITORING ECG ELECTRODE | Conmed Andover Medical, Inc. | 1994-11-22 | 57 | 0 |
| K944849 | 2700 CLEARTRACE RADIOTRANSLUCENT MONITORING ECG ELECTROBE | Conmed Andover Medical, Inc. | 1994-10-17 | 17 | 0 |
| K942718 | CLOTH TENS/BNES ELECTRODE | Conmed Andover Medical, Inc. | 1994-09-22 | 105 | 0 |
| K941839 | DISPOSABLE SURGICAL CABLE | Conmed Andover Medical, Inc. | 1994-07-27 | 105 | 0 |
| K942925 | CONMED ANDOVER MED ECG ELECTRODES | Conmed Andover Medical, Inc. | 1994-07-20 | 28 | 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