FDA product code KPH: Catheter, Rectal For Continent Ileostomy

KPH is the FDA product code for catheter, rectal for continent ileostomy. It is a Class I device, regulated under 21 CFR 876.5030 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 1 510(k) submission under KPH. The average 510(k) review took 17 days (median 17).

Classification

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

Top KPH applicants

Most recent KPH clearances

Recalls for KPH devices

openFDA lists no recalls for product code KPH.

Frequently asked questions

What is FDA product code KPH?

KPH is the FDA product code for catheter, rectal for continent ileostomy. It is a Class I device, regulated under 21 CFR 876.5030 and reviewed by the Gastroenterology and Urology panel.

What device class is KPH?

Class I, regulation 21 CFR 876.5030. Typical premarket route: 510(k) exempt.

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

Across 1 cleared submissions the average was 17 days from receipt to decision (median 17).

Which companies have the most KPH clearances?

Waters Instruments, Inc. (1).

Next steps

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