# K151095: Circumplast Circumcision Device

- Pathway: 510(k) (Traditional)
- Applicant: Novadien Healthcare
- Decided: Sep 18, 2015 after 148 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.
1 later device descends from it; 1 cites it directly.
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.

## Most influential descendants
- K221356: Wee Bell (2023), 0 descendants of its own

## Indications for use
The Circumplast single use circumcision device is intended to be used to perform circumcisions on infant males. This device consists of two components: Circumplast Circumcision Device and Ligature. The Ligature was tested for use with Circumplast Circumcision Device only.

Source page: https://510kreport.com/device/K151095
Methodology: https://510kreport.com/methodology