# K033721: Vascular Solutions Auto-Fill Syringe Kit

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Feb 13, 2004 after 79 days
- Product code: FMF (Syringe, Piston)
- 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have 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) Disposable Coronary Control Syringe: named in the summary without a submission number
- (no number) Merit Administration Set: named in the summary without a submission number
- (no number) KMI Repetitive Injection kit: named in the summary without a submission number
- (no number) fluid administration set: named in the summary without a submission number

## Most influential descendants
- K063851: Auto-Fill Syringe Kit, Model 7600 (2007), 1 descendant of its own
- K131661: Infusion Syringe Set (2013), 0 descendants of its own

## Indications for use
The Auto-Fill™ Syringe Kit is indicated for the introduction of dilute lidocaine solutions into subcutaneous tissues for the purposes of tumescent local anesthesia.

Source page: https://510kreport.com/device/K033721
Methodology: https://510kreport.com/methodology