# K143522: Presto Inflation Device

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jan 12, 2015 after 31 days
- Product code: MAV (Syringe, Balloon Inflation)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K955869 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955869: Scimed Encore 26 Inflation Device/Encore 30 Inflation Device, Scimed Life Systems, Inc. (1996) Summary page 4.

## Indications for use
The Presto™ Inflation Device is indicated for use with angioplasty balloon dilatation catheters to create and monitor the pressure in the angioplasty balloon dilatation catheter and to deflate the angioplasty balloon dilatation catheter.

Source page: https://510kreport.com/device/K143522
Methodology: https://510kreport.com/methodology