# K963428: Umbilical Clamp and Cutter

- Pathway: 510(k) (Traditional)
- Applicant: R.O.S.T. Medical Development, Inc.
- Decided: Apr 1, 1997 after 214 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
No predicates in its family tree.
3 later devices descend 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K982464: SCC-23 Safety Clamp and Cutter (1998), 2 descendants of its own
- K011621: Koala Clamp, Koala Clamp and Cutter (2001), 1 descendant of its own
- K152350: Regular and Special Umbilical Cord Clamp and Cutter (2016), 0 descendants of its own

Source page: https://510kreport.com/device/K963428
Methodology: https://510kreport.com/methodology