# K142163: Male Circumcision Kits:Rapideclamp

- Pathway: 510(k) (Traditional)
- Applicant: Medicfit Technology Sdn Bhd
- Decided: Apr 20, 2015 after 257 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: 2 generations back to K032091 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 4.
- K121789: Shangring, Wuhu Snna Medical Treatment Appliance Technology C (2012) Summary page 4.

## Indications for use
Circumcision of foreskin of males from infant to adult by circumferential excision of the foreskin or prepuce at or near the level of coronal sulcus, with minimal amount of preputial skin remaining.

Source page: https://510kreport.com/device/K142163
Methodology: https://510kreport.com/methodology