FDA product code ODR: Electrosurgical Patient Return Electrode
ODR is the FDA product code for electrosurgical patient return electrode. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel. FDA has cleared 3 510(k) submissions under ODR, from 3 different applicants. The average 510(k) review took 146 days (median 192).
Definition
Ground pad used to finish circuit during electrosurgery. A single use, non-sterile dispersive electrode with a pre-attached cord used to adhere to the patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient.
Classification
| Field | Value |
|---|---|
| Device name | Electrosurgical Patient Return Electrode |
| Device class | Class II |
| Regulation | 21 CFR 878.4400 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Top ODR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Top-Rank Health Care Co., Ltd. | 1 | 2016-08-19 |
| Bio-Med USA, Inc. | 1 | 2012-12-20 |
| Ventlab Corp. | 1 | 2008-08-13 |
Most recent ODR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K160366 | Top-Rank Health Care Co., Ltd. | Electrosurgical disposable grounding pads | 2016-08-19 | 192 |
| K121268 | Bio-Med USA, Inc. | WANDY DISPERSVIE ELECTRODE | 2012-12-20 | 238 |
| K082204 | Ventlab Corp. | SERIES SY DISPOSABLE ELECTROSURGICAL PAD | 2008-08-13 | 8 |
Recalls for ODR devices
openFDA lists no recalls for product code ODR.
Frequently asked questions
What is FDA product code ODR?
ODR is the FDA product code for electrosurgical patient return electrode. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel.
What device class is ODR?
Class II, regulation 21 CFR 878.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code ODR?
Across 3 cleared submissions the average was 146 days from receipt to decision (median 192).
Which companies have the most ODR clearances?
Top-Rank Health Care Co., Ltd. (1); Bio-Med USA, Inc. (1); Ventlab Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ODR
- Run a recall and safety report across every ODR manufacturer
- Watch product code ODR 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 General and Plastic Surgery product codes · FDA product code lookup