# K112209: Prefilled Catheter Inflation Syringe

- Pathway: 510(k) (Special)
- Applicant: Avail Medical Products, Inc.
- Decided: Sep 8, 2011 after 38 days
- Product code: KNY (Accessories, Catheter, G-U)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K090121: Pre-Filled Catheter Inflation Syringe, Avail Medical Products, Inc. (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Avail Sterile Water Filled Syringe is intended to be used to provide a sterile liquid for catheter inflation after insertion.

Source page: https://510kreport.com/device/K112209
Methodology: https://510kreport.com/methodology