# K910546: Piggy Lock Needle Housing

- Pathway: 510(k) (Traditional)
- Applicant: Icu Medical, Inc.
- Decided: Apr 29, 1991 after 82 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 1 cites it directly.
0 of 13 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
- K970485: Smartsite Access Pin (1997), 11 descendants of its own
- K052790: Smartsite Vented Vial  Access Device, Model TBD (2005), 5 descendants of its own
- K002689: Swabsite Swabbable Valve, Model 245000 (2001), 3 descendants of its own
- K151963: SmartSite Vented Vial Access Device (2015), 1 descendant of its own
- K132863: Smartsite Vialshield (2013), 1 descendant of its own

Source page: https://510kreport.com/device/K910546
Methodology: https://510kreport.com/methodology