# K822083: U-100 Insulin Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Aug 16, 1982 after 35 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.
89 later devices descend from it; 4 cite it directly.
1 of 90 devices in its family (counting itself) has 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
- K992802: Terumo U-100 Insulin Syringe (1999), 84 descendants of its own
- 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

Source page: https://510kreport.com/device/K822083
Methodology: https://510kreport.com/methodology