# K023271: Terumo Syringe with/Without Needle

- Pathway: 510(k) (Abbreviated)
- Applicant: Terumo Medical Corp.
- Decided: Dec 18, 2002 after 78 days
- Product code: FMF (Syringe, Piston)
- 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 K771205 (1977). 2 ancestors in all.
73 later devices descend from it; 4 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980181: Terumo Disposable Hypodermc Syringe, Terumo Medical Corp. (1998) Summary page 1.

## 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
- K052034: Terumo Syringe with/Without Needle (2005), 39 descendants of its own
- K063613: Modification to Terumo Syringe with/Without Needle (2006), 36 descendants of its own
- K083514: Terumo Syringe with/Without Needle (2009), 34 descendants of its own

## Indications for use
The Terunio Syringe with/without needle is intended to be used €or medical purposes to inject fluids into or withdraw fluids from the body.

Source page: https://510kreport.com/device/K023271
Methodology: https://510kreport.com/methodology