FDA product code DRO: Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
DRO is the FDA product code for pacemaker, cardiac, external transcutaneous (non-invasive). It is a Class II device, regulated under 21 CFR 870.5550 and reviewed by the Cardiovascular panel. FDA has cleared 84 510(k) submissions under DRO, from 30 different applicants. The average 510(k) review took 105 days (median 88). FDA has posted 22 recalls for DRO devices.
Classification
| Field | Value |
|---|---|
| Device name | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) |
| Device class | Class II |
| Regulation | 21 CFR 870.5550 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every DRO clearance
Top DRO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cardiac Resucitator Corp. | 13 | 1987-06-24 |
| Physio-Control Corp. | 10 | 1995-12-29 |
| Cardiotronics, Inc. | 9 | 1991-05-02 |
| Medac, Inc. | 8 | 1988-01-27 |
| Katecho, Inc. | 4 | 2001-10-12 |
25 more applicants have DRO clearances. See the full list in Caduvo.
Most recent DRO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K012404 | Katecho, Inc. | K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85 | 2001-10-12 | 74 |
| K012218 | The Ludlow Company LP | LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES | 2001-10-12 | 88 |
| K000660 | Medical Data Electronics | ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413 | 2000-03-28 | 29 |
| K983232 | Tz Medical, Inc. | PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT | 1999-09-15 | 366 |
| K983196 | Tz Medical, Inc. | PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S) | 1999-09-15 | 369 |
Recalls for DRO devices
22 product recalls in 6 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-03-10.
| Year | Recalls |
|---|---|
| 2020 | 12 |
Frequently asked questions
What is FDA product code DRO?
DRO is the FDA product code for pacemaker, cardiac, external transcutaneous (non-invasive). It is a Class II device, regulated under 21 CFR 870.5550 and reviewed by the Cardiovascular panel.
What device class is DRO?
Class II, regulation 21 CFR 870.5550. Typical premarket route: 510(k).
How long does a 510(k) take for product code DRO?
Across 84 cleared submissions the average was 105 days from receipt to decision (median 88).
Which companies have the most DRO clearances?
Cardiac Resucitator Corp. (13); Physio-Control Corp. (10); Cardiotronics, Inc. (9); Medac, Inc. (8); Katecho, Inc. (4).
Have DRO devices been recalled?
Yes: 22 product recalls across 6 recall events; the most recent began 2020-03-10.
Next steps
- Run an FDA pathway report with predicate devices for product code DRO
- Run a recall and safety report across every DRO manufacturer
- Watch product code DRO 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