# K243367: Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)

- Pathway: 510(k) (Traditional)
- Applicant: Minnesota Medical Technologies
- Decided: Jul 22, 2025 after 265 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: 3 generations back to K864218 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122003: Renew Insert, Renew Medical, Inc. (2012) Summary page 5.

## Indications for use
The fecal incontinence insert is indicated for the management of accidental bowel leakage (ABL) due to bowel incontinence. The rectal 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/K243367
Methodology: https://510kreport.com/methodology