# K925058: Bard Ambu Pump Spik Tub Set Pacret Provid Pump Set

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Aug 3, 1993 after 301 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K161323: Solution Set for Epidural Use (2016), 0 descendants of its own

## Recalls of this device
- May 31, 2011 · Not classified · Z-2708-2011: The lot of Baxter Solution Set for Epidural Use is being recalled because the position of the slide clamp and roller clamp may have been reversed during assembly. The reversed orientation of the slide

Source page: https://510kreport.com/device/K925058
Methodology: https://510kreport.com/methodology