# K994367: Umbilical Cord Clamp

- Pathway: 510(k) (Traditional)
- Applicant: Medical Sales Co.
- Decided: Mar 17, 2000 after 81 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 K894646 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990737: 'Ecurline Umbilical Cord Clamp #3500, Precision Dynamics Corp. (1999) Summary page 1.

## Indications for use
Sterile, single-use, disposable umbilical cord clamp, used to clamp over the umbilical cord of a newborn at delivery. The device is used to hold the cord securely and prevent blood loss and seepage as the cord dries and shrinks after the birth, prior to and after cutting.

Source page: https://510kreport.com/device/K994367
Methodology: https://510kreport.com/methodology