# K053188: Reprocessed Baloon Inflation Device

- Pathway: 510(k) (Traditional)
- Applicant: Sterilmed, Inc.
- Decided: May 4, 2006 after 170 days
- Product code: NKU (Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 1 (0 Class I)
- 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 1.

## Recalls of this device
- Aug 8, 2008 · Not classified · Z-0546-2009: SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of th

## Indications for use
The reprocessed Balloon Inflation Device is intended for use with balloon dilatation catheters to create and monitor pressure in the balloon and to deflate the balloon.

Source page: https://510kreport.com/device/K053188
Methodology: https://510kreport.com/methodology