# K090121: Pre-Filled Catheter Inflation Syringe

- Pathway: 510(k) (Special)
- Applicant: Avail Medical Products, Inc.
- Decided: Apr 15, 2009 after 84 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
Longest line of descent: 1 generation back to K952414 (1995). 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)
- K952414: Prefilled Syringe for Inflation of Foley Catheter, Acacia Laboratories, Inc. (1995) Summary page 1.

## Indications for use
The Avail Sterile, Latex Free, Water Filled Syringe is intended to be used to provide sterile water for catheter inflation after insertion.

Source page: https://510kreport.com/device/K090121
Methodology: https://510kreport.com/methodology