# K051762: Saf-T-Syringe/Saf-T-Needle

- Pathway: 510(k) (Traditional)
- Applicant: Safety Medical International, Incorporated
- Decided: Sep 23, 2005 after 85 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: 1 generation back to K946219 (1995). 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)
- K946219: Pop-N-Lok Syringe, Retractable Technologies, Inc. (1995) Summary page 1.
- K011103: BD Spring Based Syringe, Bd (2001) Summary page 1.

## Indications for use
The Saf-T-Syringe's primary intended use is to provide a safe, accurate and reliable method of injecting medication into a patient. The syringe is available in a 3cc, 5cc and 10cc with various needle sizes. The needle automatically withdraws and prevents accidental needle sticks. 3cc, 5cc, and 10cc Syringes are available for:

Source page: https://510kreport.com/device/K051762
Methodology: https://510kreport.com/methodology