FDA product code IRT: Pad, Heating, Powered

IRT is the FDA product code for pad, heating, powered. It is a Class II device, regulated under 21 CFR 890.5740 and reviewed by the Physical Medicine panel. FDA has cleared 42 510(k) submissions under IRT, 2 in the last five years, from 33 different applicants. The average 510(k) review took 177 days (median 154); 245 days on average over the last three years. FDA has posted 24 recalls for IRT devices, 5 initiated in the last five years.

Classification

510(k) clearances per year for IRT

Top IRT applicants

28 more applicants have IRT clearances. See the full list in Caduvo.

Most recent IRT clearances

Recalls for IRT devices

24 product recalls in 7 recall events; 5 initiated in the last five years and 4 still open. Most recent: 2026-02-18.

Frequently asked questions

What is FDA product code IRT?

IRT is the FDA product code for pad, heating, powered. It is a Class II device, regulated under 21 CFR 890.5740 and reviewed by the Physical Medicine panel.

What device class is IRT?

Class II, regulation 21 CFR 890.5740. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code IRT?

Across 42 cleared submissions the average was 177 days from receipt to decision (median 154).

Which companies have the most IRT clearances?

Conair Corp. (7); mibeTec GmbH (2); Sunbeam Health Division (2); The Gillette Company (2); Riemser Pharma (1).

Have IRT devices been recalled?

Yes: 24 product recalls across 7 recall events; the most recent began 2026-02-18.

Next steps

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