# K011621: Koala Clamp, Koala Clamp and Cutter

- Pathway: 510(k) (Traditional)
- Applicant: Maternus, Inc.
- Decided: Aug 10, 2001 after 77 days
- Product code: HFW (Clamp, Umbilical)
- 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 K963428 (1997). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982464: SCC-23 Safety Clamp and Cutter, Women First Healthcare, Inc. (1998) Summary page 1.

## Most influential descendants
- K152350: Regular and Special Umbilical Cord Clamp and Cutter (2016), 0 descendants of its own

## Indications for use
The indications for use of the Koala Clamp & Cutter are to simultaneously clamp and cut the umbitical cord.

Source page: https://510kreport.com/device/K011621
Methodology: https://510kreport.com/methodology