# K032091: Smart Klamp Various by Size

- Pathway: 510(k) (Traditional)
- Applicant: Emergogroup, Inc.
- Decided: Mar 8, 2004 after 245 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
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Kilejian Circumcisor: named in the summary without a submission number
- (no number) Gomco Circumcision Clamp: named in the summary without a submission number
- (no number) Mogan Circumcision Clamp: named in the summary without a submission number
- (no number) Hollister Plastibell: named in the summary without a submission number

## Most influential descendants
- K151095: Circumplast Circumcision Device (2015), 1 descendant of its own
- K121789: Shangring (2012), 1 descendant of its own
- K221356: Wee Bell (2023), 0 descendants of its own
- K142163: Male Circumcision Kits:Rapideclamp (2015), 0 descendants of its own
- K103695: Prepex System (2012), 0 descendants of its own

## Indications for use
Circumcision of newborns and older males, defined as 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/K032091
Methodology: https://510kreport.com/methodology