# K060002: Ritract Safety Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Ritract, Ltd.
- Decided: Jun 2, 2006 after 150 days
- Product code: MEG (Syringe, Antistick)
- 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011103: BD Spring Based Syringe, Bd (2001) Summary page 1.
- K030683: Nipro Disposable Syringes, Nipro Medical Corp. (2003) Summary page 1.

## Indications for use
The Ritract Safety Syringe is a sterile, single-use, disposable, non-reusable, auto-retracting safety syringe which is intended for injection of fluids into the body, while reducing the risk of sharps injury and the potential for syringe reuse.

Source page: https://510kreport.com/device/K060002
Methodology: https://510kreport.com/methodology