FDA product code DRK: Dc-Defibrillator, High Energy, (Including Paddles)
DRK is the FDA product code for dc-defibrillator, high energy, (including paddles). It is a Class III device, regulated under 21 CFR 870.5300 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under DRK. The average 510(k) review took 48 days (median 48).
Definition
PMA to be filed by 12/26/96 (FR 50706 (9/27/96))
Classification
| Field | Value |
|---|---|
| Device name | Dc-Defibrillator, High Energy, (Including Paddles) |
| Device class | Class III |
| Regulation | 21 CFR 870.5300 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | PMA |
Compare with all 510(k) review times · Search every DRK clearance
Top DRK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| National Custom Ent., Inc. | 1 | 1993-10-07 |
Most recent DRK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K934067 | National Custom Ent., Inc. | POWRPAK REPLACEMENT BATTERIES FOR PHISIO-CONTROL LIFEPAK 5/10 | 1993-10-07 | 48 |
Recalls for DRK devices
openFDA lists no recalls for product code DRK.
Frequently asked questions
What is FDA product code DRK?
DRK is the FDA product code for dc-defibrillator, high energy, (including paddles). It is a Class III device, regulated under 21 CFR 870.5300 and reviewed by the Cardiovascular panel.
What device class is DRK?
Class III, regulation 21 CFR 870.5300. Typical premarket route: PMA.
How long does a 510(k) take for product code DRK?
Across 1 cleared submissions the average was 48 days from receipt to decision (median 48).
Which companies have the most DRK clearances?
National Custom Ent., Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DRK
- Run a recall and safety report across every DRK manufacturer
- Watch product code DRK 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