# K083770: Coloplast Peristeen Anal Irrigation (Pai) System

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast A/S
- Decided: Nov 23, 2009 after 340 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K813526 (1982). 4 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023344: Indwelling Fecal Management System-Non-Sterile, Bowel Management Systems, LLC (2002) Summary page 1.
- (no number) Aresure Enema Cleansing Bag: named in the summary without a submission number

## Most influential descendants
- K103254: Peristeen Anal Irrigation System, Irrigation Accessory Unit, Irrigation Rectal Catheter, System Strap, Irrigation Tube (2011), 4 descendants of its own
- K112860: Peristeen Anal Irrigation System, Peristeen Anal Irrigation Accessory Unit, Peristeen Anal Irrigation Rectal Catheter (2012), 3 descendants of its own
- K140310: Peristeen Anal Irrigation System (2015), 2 descendants of its own
- K170487: Navina Classic System (2017), 1 descendant of its own
- K190977: Navina Smart System, Navina Classic System (2019), 0 descendants of its own

## Indications for use
The Peristeen Anal Irrigation (PAI) System is intended to instill water into the colon through a rectal catheter - which incorporates an inflatable balloon - inserted into the rectum to promote evacuation of the contents of the lower colon. The PAI System is indicated for use by adolescent (12 years - < 18 years old), transitional adolescent (18 - < 21 years old) and adult spinal cord injury patients with neurogenic bowel dysfunction who suffer from fecal incontinence, chronic constipation, and/or time-consuming bowel management procedures.

Source page: https://510kreport.com/device/K083770
Methodology: https://510kreport.com/methodology