# K212911: Konig Mogen Clamp

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Nov 18, 2022 after 431 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: 3 generations back to K935491 (1994). 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)
- K100916: Medicon Mogen Clamp, Medicon EG (2010) Summary page 4.

## Indications for use
The Konig Mogen Clamp is an instrument used in a medical procedure to compress the foreskin of the penis during the circumcision of a male infant or child only.

Source page: https://510kreport.com/device/K212911
Methodology: https://510kreport.com/methodology