# K021055: Busse Umbilical Cord Clamp Cutter

- Pathway: 510(k) (Traditional)
- Applicant: Busse Hospital Disposables, Inc.
- Decided: Apr 29, 2002 after 28 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: 1 generation back to K781548 (1978). 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)
- K010835: Posi-Grip Umbilical Cord Clamp, Sterile, Model 384, Posi-Grip Umbilical Cord Clamp, Non-Sterile, Model 385, Busse Hospital Disposables, Inc. (2001) Summary page 1.
- K994263: Securline Umbilical Cord Clamp Clipper #3540, Precision Dynamics Corp. (2000) Summary page 1.
- K781548: Umbilical Cord Clamp, Hollister, Inc. (1978) Summary page 1.

## Indications for use
The intended use is to cut the umbilical cord clamp off a newborn’s umbilical cord.

Source page: https://510kreport.com/device/K021055
Methodology: https://510kreport.com/methodology