FDA product code MPU: Source, Chemiluminescent Light

MPU is the FDA product code for source, chemiluminescent light. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 2 510(k) submissions under MPU. The average 510(k) review took 310 days (median 310). FDA has posted 1 recall for MPU devices.

Classification

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

Top MPU applicants

Most recent MPU clearances

Recalls for MPU devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2003-08-07.

Frequently asked questions

What is FDA product code MPU?

MPU is the FDA product code for source, chemiluminescent light. It is a Class II device, regulated under 21 CFR 884.4530 and reviewed by the Obstetrics and Gynecology panel.

What device class is MPU?

Class II, regulation 21 CFR 884.4530. Typical premarket route: 510(k).

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

Across 2 cleared submissions the average was 310 days from receipt to decision (median 310).

Which companies have the most MPU clearances?

Trylon Corp. (2).

Have MPU devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2003-08-07.

Next steps

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