# K163597: VacLok AT Vacuum Syringe

- Pathway: 510(k) (Abbreviated)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jul 27, 2017 after 218 days
- Product code: PUR (Vacuum Syringe)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K980580 (1998). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070936: Welmed Hypodermic Syringe, Welmed, Inc. (2007) Summary page 4.

## Most influential descendants
- K233069: Removal System Large Bore 60 cc Syringe (2024), 0 descendants of its own

## Indications for use
VacLok™ AT Vacuum Syringe is used to inject fluids into, or withdraw fluids from the body. It can also be used in cases where a vacuum syringe is preferred (e.g. thrombus, abscess fluid, bile, urine etc.).

Source page: https://510kreport.com/device/K163597
Methodology: https://510kreport.com/methodology