# K083193: Revac Auto Retractable Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Revolutions Medical Corporation, Inc.
- Decided: Feb 13, 2009 after 107 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
Longest line of descent: 1 generation back to K000860 (2000). 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)
- K000860: Futura Safety Syringe, Sheila W. Pickering (2000) Summary page 1.

## Indications for use
The Reverse Vaccuum (RevVac) Safety Syringe, is a sterile, single use, disposable, auto-retracting safety piston syringe which is intended for injection of fluid into the body, while reducing the risk of sharps injury and the potential for syringe reuse. The device is intended for use for subcutaneous and intramuscular use.

Source page: https://510kreport.com/device/K083193
Methodology: https://510kreport.com/methodology