# K994253: Vaclok Syringe

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jan 5, 2000 after 19 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
79 later devices descend from it; 4 cite it directly.
1 of 80 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Merit Coronary Control Syringe: named in the summary without a submission number

## Most influential descendants
- K023272: Disposable Aspiration Needle NA-200H (2002), 63 descendants of its own
- K050503: Single Use Aspiration Needle NA-201SX-4022 (2005), 28 descendants of its own
- K100712: Resound Endoscopic Ultrasound Aspiration Needle (2010), 27 descendants of its own
- K110030: Expect Endoscopic Aspiration Needle (2011), 26 descendants of its own
- K112198: Expect Endoscopic Ultrasound Aspiration Needle (2011), 16 descendants of its own

## Recalls of this device
- Oct 20, 2021 · Class II · Z-0202-2022: Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.
- Oct 22, 2010 · Not classified · Z-0504-2011: Packaging for syringes may have holes which would compromise the sterility of the package contents.
- Oct 22, 2010 · Not classified · Z-0505-2011: Packaging for syringes may have holes which would compromise the sterility of the package contents.
- Oct 22, 2010 · Not classified · Z-0506-2011: Packaging for syringes may have holes which would compromise the sterility of the package contents.
- Oct 22, 2010 · Not classified · Z-0503-2011: Packaging for syringes may have holes which would compromise the sterility of the package contents.
- Oct 2, 2003 · Not classified · Z-0308-04: Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
- Oct 2, 2003 · Not classified · Z-0310-04: Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
- Oct 2, 2003 · Not classified · Z-0307-04: Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
- Oct 2, 2003 · Not classified · Z-0309-04: Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
- Oct 2, 2003 · Not classified · Z-0311-04: Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
- Oct 1, 2003 · Not classified · Z-0139-04: There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or 

## Indications for use
The VACLOK Syringe is intended to be used by a cardiologist or radiologist during angiographic or radiologic procedures.

Source page: https://510kreport.com/device/K994253
Methodology: https://510kreport.com/methodology