# K122003: Renew Insert

- Pathway: 510(k) (Traditional)
- Applicant: Renew Medical, Inc.
- Decided: Oct 26, 2012 after 109 days
- Product code: PBP (Rectal Insert)
- 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: 2 generations back to K864218 (1987). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042431: PROCON2, Incontinent Control Devices, Inc. (2005) Summary page 1.

## Most influential descendants
- K243367: Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) (2025), 0 descendants of its own

## Indications for use
The Renew Insert is indicated for the management of accidental bowel leakage due to bowel incontinence. The Renew Insert is designed for self-insertion to seal and help prevent the involuntary leakage of stool from the rectum.

Source page: https://510kreport.com/device/K122003
Methodology: https://510kreport.com/methodology