# K003337: Hem-O-Lok SMX, Model 544220; Hem-O-Lok ML, Model 544230; Hem-O-Lok MLX, Model 544240

- Pathway: 510(k) (Traditional)
- Applicant: Weck Closure Systems
- Decided: Dec 21, 2000 after 57 days
- Product code: FZP (Clip, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K062914: Hem-O-Lok Ligation Clip (2006), 4 descendants of its own
- K133202: Hem-O-Lok Ligating Clip (2013), 3 descendants of its own
- K232970: Hem-o-lok® Ligating Clips (2024), 1 descendant of its own
- K251054: Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips (2025), 0 descendants of its own
- K181852: Percuvance Percutaneous Surgical System (2018), 0 descendants of its own

## Recalls of this device
- Apr 12, 2006 · Not classified · Z-1096-06: The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the 
- Apr 12, 2006 · Not classified · Z-1097-06: The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the 

Source page: https://510kreport.com/device/K003337
Methodology: https://510kreport.com/methodology