Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Qmed, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
125 daysmedian FDA review time
214 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972991 | MONITOR ONE NDX | Qmed, Inc. | 1998-12-03 | 478 | 0 |
| K932109 | PROFILOMAT | Qmed, Inc. | 1993-12-03 | 214 | 0 |
| K921476 | INTERP-1000 | Qmed, Inc. | 1992-10-21 | 205 | 0 |
| K897121 | QEKG ELECTROCARDIOGRAPH | Qmed, Inc. | 1990-04-30 | 125 | 0 |
| K873591 | A.R.M. (ASPEN RETURN MONITOR) | Qmed, Inc. | 1987-09-30 | 26 | 0 |
| K862377 | QMED SELF ADHERING ELECTRODE | Qmed, Inc. | 1986-09-26 | 94 | 0 |
| K863091 | BICORD BY QMED | Qmed, Inc. | 1986-08-29 | 16 | 0 |
| K861437 | QMED SYSTEM 2150 | Qmed, Inc. | 1986-05-20 | 33 | 0 |
| K843559 | KLEENIT BY QMED | Qmed, Inc. | 1984-10-24 | 44 | 0 |
| K841172 | MONITOR ONE | Qmed, Inc. | 1984-07-27 | 130 | 0 |
| K840465 | Q-MED ELECTRODE | Qmed, Inc. | 1984-06-19 | 137 | 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