FDA product code ISP: Valve, Prosthesis

ISP is the FDA product code for valve, prosthesis. It is a Class I device, regulated under 21 CFR 890.3420 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under ISP. The average 510(k) review took 57 days (median 57). FDA has posted 1 recall for ISP devices.

Classification

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

Top ISP applicants

Most recent ISP clearances

Recalls for ISP devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-06-23.

Frequently asked questions

What is FDA product code ISP?

ISP is the FDA product code for valve, prosthesis. It is a Class I device, regulated under 21 CFR 890.3420 and reviewed by the Physical Medicine panel.

What device class is ISP?

Class I, regulation 21 CFR 890.3420. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 57 days from receipt to decision (median 57).

Which companies have the most ISP clearances?

Erich Jaeger, Inc. (1).

Have ISP devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2009-06-23.

Next steps

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