FDA product code OIR: Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

OIR is the FDA product code for diaphragmatic/phrenic nerve laparoscopically-implanted stimulator. It is a Class III device, reviewed by the Anesthesiology panel. Devices under OIR reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 2 recalls for OIR devices, 2 initiated in the last five years.

Definition

The device is intended for use in patients with stable, high spinal cord injuries with stimulatable diaphragms, but who lack control of their diaphragms. The device is indicated to allow the patients to breathe without the assistance of a mechanical ventilator for at least 4 continuous hours a day. For use only in patients 18 years of age or older.

Classification

Recalls for OIR devices

2 product recalls in 2 recall events; 2 initiated in the last five years and 0 still open. Most recent: 2022-07-11.

Frequently asked questions

What is FDA product code OIR?

OIR is the FDA product code for diaphragmatic/phrenic nerve laparoscopically-implanted stimulator. It is a Class III device, reviewed by the Anesthesiology panel.

What device class is OIR?

Class III. Typical premarket route: PMA.

Have OIR devices been recalled?

Yes: 2 product recalls across 2 recall events; the most recent began 2022-07-11.

Next steps

• Run an FDA pathway report with predicate devices for product code OIR
• Run a recall and safety report across every OIR manufacturer
• Watch product code OIR 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.

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