# K152350: Regular and Special Umbilical Cord Clamp and Cutter

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Feite Medical Device Co., Ltd.
- Decided: Jun 28, 2016 after 313 days
- Product code: NBZ (Clamp And Cutter, 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: 3 generations back to K963428 (1997). 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)
- K011621: Koala Clamp, Koala Clamp and Cutter, Maternus, Inc. (2001) Summary page 4.

## Indications for use
Regular and Special Umbilical Cord Clamp and Cutter are intended for use in simultaneously clamping and cutting the umbilical cord of the new born baby at delivery

Source page: https://510kreport.com/device/K152350
Methodology: https://510kreport.com/methodology