# K103695: Prepex System

- Pathway: 510(k) (Traditional)
- Applicant: Circ Medtech
- Decided: Jan 10, 2012 after 389 days
- Product code: HFX (Clamp, Circumcision)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K032091 (2004). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032091: Smart Klamp Various by Size, Emergogroup, Inc. (2004) Summary page 1.

## Indications for use
PrePex is indicated for circumcision of adult males. Prepex is intended to be placed and removed by a health care professional trained in male circumcision and in use of the PrePex device.

Source page: https://510kreport.com/device/K103695
Methodology: https://510kreport.com/methodology