# K041332: Joey Clamp Opening Tool

- Pathway: 510(k) (Traditional)
- Applicant: Maternus, Inc.
- Decided: Jun 25, 2004 after 37 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 K994263 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994263: Securline Umbilical Cord Clamp Clipper #3540, Precision Dynamics Corp. (2000) Summary page 1.

## Indications for use
The indications for use of the Joey Clamp Opening Tool is to open the Joey Clamp® umbilical cord clamp.

Source page: https://510kreport.com/device/K041332
Methodology: https://510kreport.com/methodology