FDA product code IWO: Apron, Protective

IWO is the FDA product code for apron, protective. It is a Class I device, regulated under 21 CFR 892.6500 and reviewed by the Radiology panel. FDA has cleared 1 510(k) submission under IWO. The average 510(k) review took 11 days (median 11). FDA has posted 13 recalls for IWO devices, 13 initiated in the last five years.

Classification

Compare with all 510(k) review times · Search every IWO clearance

Top IWO applicants

Most recent IWO clearances

Recalls for IWO devices

13 product recalls in 1 recall events; 13 initiated in the last five years and 13 still open. Most recent: 2026-02-11.

Frequently asked questions

What is FDA product code IWO?

IWO is the FDA product code for apron, protective. It is a Class I device, regulated under 21 CFR 892.6500 and reviewed by the Radiology panel.

What device class is IWO?

Class I, regulation 21 CFR 892.6500. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 11 days from receipt to decision (median 11).

Which companies have the most IWO clearances?

Worldwide Dental, Inc. (1).

Have IWO devices been recalled?

Yes: 13 product recalls across 1 recall events; the most recent began 2026-02-11.

Next steps

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