# K024249: Terumo Surguard Safety Syringe

- Pathway: 510(k) (Abbreviated)
- Applicant: Terumo Medical Corp.
- Decided: Feb 21, 2003 after 60 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: 3 generations back to K904198 (1990). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K822083: U-100 Insulin Syringe, Terumo Medical Corp. (1982) Summary page 2.
- K980796: Terumo Allergy Syringe, Terumo Corp. (1998) Summary page 2.
- K011925: Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic Needle-Pro Syringe & Needle with Needle Protectio, Sims Portex, Inc. (2001)

## Most influential descendants
- K063755: Portex Hypodermic Needle-Pro Fixed Needle Syringe (2007), 2 descendants of its own
- K093176: Med-Lok (2010), 0 descendants of its own
- K072482: Hypodermic Needle-Pro Safety Allergy Tray (2007), 0 descendants of its own

## Indications for use
The Surguard Safety Syringe is a device intended for the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. The syringe will also be used to withdraw medication from vials. This device is intended for insulin, allergy, or general use injections. Additionally, after withdrawing the needle from the patient, the safety feature can be manually activated to cover the needle to minimize the risk of accidental needlestick.

Source page: https://510kreport.com/device/K024249
Methodology: https://510kreport.com/methodology