# K040531: Terumo SURGUARD2 Safety Needle

- Pathway: 510(k) (Special)
- Applicant: Terumo Medical Corp.
- Decided: Mar 23, 2004 after 22 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- 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). 7 ancestors in all.
67 later devices descend from it; 2 cite it directly.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031453: Terumo Surguard 2 Safety Needle, Terumo Medical Corp. (2003) Summary page 1.
- K771203: Disp. Hypodermic Needle, Terumo America, Inc. (1977) Summary page 2.
- K012646: Terumo 30 Gauge Hypodermic Needle, Terumo Medical Corp. (2001) Summary page 2.

## Most influential descendants
- K051865: Terumo Surguard 2 Safety Needle or Similar (2005), 65 descendants of its own
- K113422: Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with Safety Needle (2012), 60 descendants of its own
- K170651: Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle (2017), 32 descendants of its own
- K192551: 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle (2020), 14 descendants of its own
- K180417: Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use (2018), 12 descendants of its own

## Indications for use
The SURGUARD2 T M SAFETY NEEDLE device for 26 to 30gauge needles is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Needle is compatible for use with standard luer slip and luer lock syringes. Additionally, after withdraw of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

Source page: https://510kreport.com/device/K040531
Methodology: https://510kreport.com/methodology