FDA product code JOR: Generator, Pulsatile Flow, Cardiopulmonary Bypass
JOR is the FDA product code for generator, pulsatile flow, cardiopulmonary bypass. It is a Class III device, regulated under 21 CFR 870.4320 and reviewed by the Cardiovascular panel. Devices under JOR reach the market by PMA; FDA lists no cleared 510(k)s for it. FDA has posted 2 recalls for JOR devices.
Definition
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any cardiopulmonary bypass pulsatile flow generator that was in commercial distribution before May 28, 1976, or that has, on or before September 21, 2004, been found to be substantially equivalent to any cardiopulmonary bypass pulsatile flow generator that was in commercial distribution before May 28, 1976. Any other cardiopulmonary bypass pulsatile flow generator shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
Classification
| Field | Value |
|---|---|
| Device name | Generator, Pulsatile Flow, Cardiopulmonary Bypass |
| Device class | Class III |
| Regulation | 21 CFR 870.4320 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | PMA |
Recalls for JOR devices
2 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-11-02.
Frequently asked questions
What is FDA product code JOR?
JOR is the FDA product code for generator, pulsatile flow, cardiopulmonary bypass. It is a Class III device, regulated under 21 CFR 870.4320 and reviewed by the Cardiovascular panel.
What device class is JOR?
Class III, regulation 21 CFR 870.4320. Typical premarket route: PMA.
Have JOR devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2010-11-02.
Next steps
- Run an FDA pathway report with predicate devices for product code JOR
- Run a recall and safety report across every JOR manufacturer
- Watch product code JOR 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