# K771205: Hypodermic Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Terumo America, Inc.
- Decided: Jul 14, 1977 after 9 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
No predicates in its family tree.
92 later devices descend from it; 6 cite it directly.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K980181: Terumo Disposable Hypodermc Syringe (1998), 88 descendants of its own
- 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

Source page: https://510kreport.com/device/K771205
Methodology: https://510kreport.com/methodology