# K943181: Dispensing Pin with One-Way Valve

- Pathway: 510(k) (Traditional)
- Applicant: B. Braun of America, Inc.
- Decided: Sep 29, 1994 after 90 days
- Product code: LHI (Set, I.V. Fluid Transfer)
- Device class: 2
- Regulation: 21 CFR 880.5440
- 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K955179: Contrast Media Set (1997), 1 descendant of its own
- K150787: Universal Spike (2015), 0 descendants of its own
- K052252: Contrast Media Transfer Sets (2005), 0 descendants of its own

## Recalls of this device
- Apr 14, 2016 · Class II · Z-1907-2016: BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units. The tears have been identified in the blister package paper, where the unit label writing i
- Apr 14, 2016 · Class II · Z-1906-2016: BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units. The tears have been identified in the blister package paper, where the unit label writing i

Source page: https://510kreport.com/device/K943181
Methodology: https://510kreport.com/methodology