# K071630: Terumo 31G Thinpro Insulin Syringe

- Pathway: 510(k) (Special)
- Applicant: Terumo Medical Corp.
- Decided: Jul 11, 2007 after 27 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: 2 generations back to K822083 (1982). 4 ancestors in all.
82 later devices descend from it; 3 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.
- K992802: Terumo U-100 Insulin Syringe, Terumo Medical Corp. (1999) Summary page 1.
- K001474: Terumo U-100 Insulin Syring, Terumo Medical Corp. (2000) 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
- 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
- K180417: Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use (2018), 12 descendants of its own

## Indications for use
The TERUMO® 31G ThinPro 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. This syringe with 31G needle is indicated for general use and for pediatric patients.

Source page: https://510kreport.com/device/K071630
Methodology: https://510kreport.com/methodology