# K072654: Patient Safe Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Retractable Technologies, Inc.
- Decided: Dec 14, 2007 after 85 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: 2 generations back to K944355 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030683: Nipro Disposable Syringes, Nipro Medical Corp. (2003) Summary page 1.

## Indications for use
The intended use of the Patient Safe SyringeTM is to aspirate fluid and inject fluids into the body. Additionally, the unique design of the syringe protects the luer tip from contact contamination prior to injection, thus reducing the risk of medication contamination and bloodstream infections resulting from luer tip contamination.

Source page: https://510kreport.com/device/K072654
Methodology: https://510kreport.com/methodology