FDA product code EXY: Uroflowmeter

EXY is the FDA product code for uroflowmeter. It is a Class II device, regulated under 21 CFR 876.1800 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 16 510(k) submissions under EXY, from 14 different applicants. The average 510(k) review took 114 days (median 93). FDA has posted 2 recalls for EXY devices, 2 initiated in the last five years.

Classification

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

Top EXY applicants

9 more applicants have EXY clearances. See the full list in Caduvo.

Most recent EXY clearances

Recalls for EXY devices

2 product recalls in 2 recall events; 2 initiated in the last five years and 1 still open. Most recent: 2026-05-29.

Frequently asked questions

What is FDA product code EXY?

EXY is the FDA product code for uroflowmeter. It is a Class II device, regulated under 21 CFR 876.1800 and reviewed by the Gastroenterology and Urology panel.

What device class is EXY?

Class II, regulation 21 CFR 876.1800. Typical premarket route: 510(k) exempt.

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

Across 16 cleared submissions the average was 114 days from receipt to decision (median 93).

Which companies have the most EXY clearances?

Life-Tech Intl., Inc. (3); Be Technologies, Inc. (1); W.O.M. World of Medicine AG (1); Albyn Medical , Ltd. (1); Dantec Medical, Inc. (1).

Have EXY devices been recalled?

Yes: 2 product recalls across 2 recall events; the most recent began 2026-05-29.

Next steps

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