# HFW: Clamp, Umbilical

- Device class: 2; regulation: 21 CFR 884.4530; FDA's rule: 510(k) exempt
- FDA decisions: 36
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1992: 3
- 1993: 1
- 1994: 2
- 1995: 2
- 1997: 4
- 1999: 2
- 2000: 3
- 2001: 4
- 2002: 2
- 2004: 2

## Most-cited predicates
- K994263: Securline Umbilical Cord Clamp Clipper #3540 (2000), cited by 2
- K781548: Umbilical Cord Clamp (1978), cited by 2
- K894646: #556 Disposable Umbilical Cord Clamp (2) (1989), cited by 2
- K011621: Koala Clamp, Koala Clamp and Cutter (2001), cited by 1
- K963428: Umbilical Clamp and Cutter (1997), cited by 1
- K010835: Posi-Grip Umbilical Cord Clamp, Sterile, Model 384, Posi-Grip Umbilical Cord Clamp, Non-Sterile, Model 385 (2001), cited by 1
- K990737: 'Ecurline Umbilical Cord Clamp #3500 (1999), cited by 1
- K880753: Umbilical Cord Clamp (1988), cited by 1

Source page: https://510kreport.com/product-code/HFW
Data by year (CSV): https://510kreport.com/product-code/HFW.csv