# K212095: SurGuard3 Safety Hypodermic Needle

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Europe N.V.
- Decided: Aug 22, 2022 after 412 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: 7 generations back to K904198 (1990). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113422: Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with Safety Needle, Terumo (Philippines) Corporation (2012) Summary page 4.
- K122249: Terumo SURGUARD3 Safety Needle & Hypodermic Syringe with Safety Needle, Terumo (Philippines) Corporation (2012) Summary page 5.

## Most influential descendants
- K251447: K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) (2025), 0 descendants of its own

## Indications for use
The TERUMO SurGuard®3 SAFETY HYPODERMIC NEEDLE is intended for use in the aspiration and injection of fluids for medical purposes. The Terumo Safety Hypodermic Needle is compatible for use with standard luer slip and luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

Source page: https://510kreport.com/device/K212095
Methodology: https://510kreport.com/methodology