# K992802: Terumo U-100 Insulin Syringe

- Pathway: 510(k) (Special)
- Applicant: Terumo Medical Corp.
- Decided: Sep 9, 1999 after 21 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 K822083 (1982). 2 ancestors in all.
84 later devices descend from it; 2 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K822083: U-100 Insulin Syringe, Terumo Medical Corp. (1982) Summary page 1.
- K955235: B-D Ultra Fine II, Micro Fine + Short Needle Insulin Syringe, Bd Becton Dickinson Vacutainer Systems Preanalytic (1996) Summary page 1.

## 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

## Indications for use
The TERUMO® U-100 Insulin Syringe, with fixed hypodermic single lumen needle, is a device intended for medical purposes for the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. This device is intended particularly for the aspiration and injection of insulin.

Source page: https://510kreport.com/device/K992802
Methodology: https://510kreport.com/methodology