FDA product code FPS: Board, Bed

FPS is the FDA product code for board, bed. It is a Class I device, regulated under 21 CFR 880.6070 and reviewed by the General Hospital panel. FDA has cleared 1 510(k) submission under FPS. The average 510(k) review took 19 days (median 19). FDA has posted 4 recalls for FPS devices.

Classification

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

Top FPS applicants

Most recent FPS clearances

Recalls for FPS devices

4 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-04-23.

Frequently asked questions

What is FDA product code FPS?

FPS is the FDA product code for board, bed. It is a Class I device, regulated under 21 CFR 880.6070 and reviewed by the General Hospital panel.

What device class is FPS?

Class I, regulation 21 CFR 880.6070. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 19 days from receipt to decision (median 19).

Which companies have the most FPS clearances?

Biomet, Inc. (1).

Have FPS devices been recalled?

Yes: 4 product recalls across 2 recall events; the most recent began 2010-04-23.

Next steps

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

All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times