# K001474: Terumo U-100 Insulin Syring

- Pathway: 510(k) (Special)
- Applicant: Terumo Medical Corp.
- Decided: Jun 9, 2000 after 29 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.
83 later devices descend from it; 1 cites it directly.
0 of 84 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
- K071630: Terumo 31G Thinpro Insulin Syringe (2007), 82 descendants of its own
- K072739: Jierui Syringes and Needles (2008), 78 descendants of its own
- K110421: Disposable Insulin Syringe (2011), 36 descendants of its own
- K112057: KDL Syringes and Needle (2011), 31 descendants of its own
- K190002: Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use (2019), 13 descendants of its own

Source page: https://510kreport.com/device/K001474
Methodology: https://510kreport.com/methodology