# K140310: Peristeen Anal Irrigation System

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast A/S
- Decided: Sep 3, 2015 after 573 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: 6 generations back to K813526 (1982). 7 ancestors in all.
2 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)
- K112860: Peristeen Anal Irrigation System, Peristeen Anal Irrigation Accessory Unit, Peristeen Anal Irrigation Rectal Catheter, Coloplast A/S (2012) Summary page 4.

## Most influential descendants
- 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 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 Peristeen Anal Irrigation System is indicated for use by children (2 years -<12 years old), adolescent (12 years - <18 years old), transitional adolescent (18 - <21 years old) and adult 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/K140310
Methodology: https://510kreport.com/methodology