# K980181: Terumo Disposable Hypodermc Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Apr 2, 1998 after 72 days
- Product code: FMF (Syringe, Piston)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K771205 (1977). 1 ancestor in all.
88 later devices descend from it; 6 cite it directly.
0 of 90 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K771205: Hypodermic Syringe, Terumo America, Inc. (1977) Summary page 1.

## Most influential descendants
- K031453: Terumo Surguard 2 Safety Needle (2003), 74 descendants of its own
- K023271: Terumo Syringe with/Without Needle (2002), 73 descendants of its own
- K040531: Terumo SURGUARD2 Safety Needle (2004), 67 descendants of its own
- 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

## Recalls of this device
- Dec 21, 2015 · Class II · Z-0731-2016: All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product.

## Indications for use
The Terumo Disposable Hypodermic Syringe, with or without hypodermic single lumen needle, is used for injecting fluids into or withdrawing fluids from the body. The syringe is designed for manual use.

Source page: https://510kreport.com/device/K980181
Methodology: https://510kreport.com/methodology