# K060643: QL Locking Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Atrion Medical Products, Inc.
- Decided: Jul 12, 2006 after 124 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: 4 generations back to K953522 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032840: Atrion Medical QL Inflation Device, Atrion Medical Products, Inc. (2004) Summary page 1.
- K040138: Viceroy Inflation Device, Merit Medical Systems, Inc. (2004) Summary page 1.

## Indications for use
The Atrion Medical QL® Locking Syringe Device is intended for single use to inject fluid into and aspirate fluid from a balloon interventional device having a recommended balloon inflation volume.

Source page: https://510kreport.com/device/K060643
Methodology: https://510kreport.com/methodology