# K980796: Terumo Allergy Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Corp.
- Decided: Apr 2, 1998 after 31 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: 1 generation back to K941657 (1994). 1 ancestor in all.
7 later devices descend from it; 3 cite it directly.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941657: BD Micro Fine, Ultra Fine, and Allergy Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1994) Summary page 2.

## Most influential descendants
- K024249: Terumo Surguard Safety Syringe (2003), 3 descendants of its own
- K063755: Portex Hypodermic Needle-Pro Fixed Needle Syringe (2007), 2 descendants of its own
- K110456: Pharmajet 0.1 ML Intradermal Needle-Free Injection System (2011), 1 descendant of its own
- K121270: Bioject Needle-Free Injection Management System (2012), 0 descendants of its own
- K093176: Med-Lok (2010), 0 descendants of its own

## Indications for use
The Terumo Allergy Syringe is intended for the preparation/mixing of allergenic extracts/prescribed substances, the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. This syringe is designed for manual use.

Source page: https://510kreport.com/device/K980796
Methodology: https://510kreport.com/methodology