Qmed, Inc.: FDA clearances and approvals
Qmed, Inc. has 11 FDA 510(k) clearances (first 1984, latest 1998), across 10 product codes in 3 review panels. Median 510(k) review time: 125 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DPS | Electrocardiograph | 2 | 2 |
| DRX | Electrode, Electrocardiograph | 1 | 1 |
| DSI | Detector And Alarm, Arrhythmia | 1 | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| HAM | Apparatus, Electrosurgical | 1 | 1 |
| LOS | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Qmed, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972991 | MONITOR ONE NDX | DPS | 1998-12-03 | 478 |
| K932109 | PROFILOMAT | DXN | 1993-12-03 | 214 |
| K921476 | INTERP-1000 | LOS | 1992-10-21 | 205 |
| K897121 | QEKG ELECTROCARDIOGRAPH | DPS | 1990-04-30 | 125 |
| K873591 | A.R.M. (ASPEN RETURN MONITOR) | GEI | 1987-09-30 | 26 |
| K862377 | QMED SELF ADHERING ELECTRODE | GXY | 1986-09-26 | 94 |
| K863091 | BICORD BY QMED | HAM | 1986-08-29 | 16 |
| K861437 | QMED SYSTEM 2150 | DXG | 1986-05-20 | 33 |
| K843559 | KLEENIT BY QMED | — | 1984-10-24 | 44 |
| K841172 | MONITOR ONE | DSI | 1984-07-27 | 130 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Qmed, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Qmed, Inc. have?
Qmed, Inc. has 11 FDA 510(k) clearances (first 1984, latest 1998), across 10 product codes in 3 review panels.
How long does FDA take to clear Qmed, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Qmed, Inc.'s cleared 510(k)s is 125 days.
What devices does Qmed, Inc. make?
Its most frequent FDA product codes are DPS (Electrocardiograph, 2); DRX (Electrode, Electrocardiograph, 1); DSI (Detector And Alarm, Arrhythmia, 1).
Has Qmed, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Qmed, Inc. Related entities may recall under other names.
Next steps
- See all 11 Qmed, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Qmed, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.