FDA product code DRL: Tester, Defibrillator
DRL is the FDA product code for tester, defibrillator. It is a Class II device, regulated under 21 CFR 870.5325 and reviewed by the Cardiovascular panel. FDA has cleared 19 510(k) submissions under DRL, from 15 different applicants. The average 510(k) review took 119 days (median 98). FDA has posted 1 recall for DRL devices.
Classification
| Field | Value |
|---|---|
| Device name | Tester, Defibrillator |
| Device class | Class II |
| Regulation | 21 CFR 870.5325 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for DRL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 59 |
| 2019 | 1 | 187 |
Compare with all 510(k) review times · Search every DRL clearance
Top DRL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bc Group International, Inc. | 2 | 2015-12-21 |
| Fluke Biomedical | 2 | 2008-12-24 |
| Guardian Angel Products, Inc. | 2 | 2003-07-11 |
| Bio-Tek Instruments, Inc. | 2 | 1995-11-17 |
| Netech Corporation | 1 | 2019-08-28 |
10 more applicants have DRL clearances. See the full list in Caduvo.
Most recent DRL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K190437 | Netech Corporation | Delta 3300 | 2019-08-28 | 187 |
| K182905 | Seaward Group | UniPulse | 2018-12-14 | 59 |
| K153210 | Bc Group International, Inc. | Defibrillator Analyzer Variable Load | 2015-12-21 | 46 |
| K110192 | Bc Group International, Inc. | DEFIBRILLATOR ANALYZER - DA-2006P | 2011-02-08 | 15 |
| K083347 | Fluke Biomedical | IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS | 2008-12-24 | 41 |
Recalls for DRL devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2015-10-28.
Frequently asked questions
What is FDA product code DRL?
DRL is the FDA product code for tester, defibrillator. It is a Class II device, regulated under 21 CFR 870.5325 and reviewed by the Cardiovascular panel.
What device class is DRL?
Class II, regulation 21 CFR 870.5325. Typical premarket route: 510(k).
How long does a 510(k) take for product code DRL?
Across 19 cleared submissions the average was 119 days from receipt to decision (median 98).
Which companies have the most DRL clearances?
Bc Group International, Inc. (2); Fluke Biomedical (2); Guardian Angel Products, Inc. (2); Bio-Tek Instruments, Inc. (2); Netech Corporation (1).
Have DRL devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2015-10-28.
Next steps
- Run an FDA pathway report with predicate devices for product code DRL
- Run a recall and safety report across every DRL manufacturer
- Watch product code DRL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Cardiovascular product codes · FDA product code lookup · 510(k) database search · 510(k) review times