# K014114: Glucopro Syringe, Model Gpsy-Xxxxxxxx

- Pathway: 510(k) (Traditional)
- Applicant: Nipro Diabetes Systems, Inc.
- Decided: Jun 26, 2002 after 194 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Disetronic Medical Systems AG, 3.15mL cartridge: named in the summary without a submission number

## Indications for use
The Glumpro syringe is intended for use in the subcutaneous infusion of insulin. The catheter of the GJucoPro (K011120) or compatible infusion set is inserted into the subcutaneous tissue of the user and it is connected to the Glucopro Syfmge. The h ~s u is h ifised from an external infbsion pump.

Source page: https://510kreport.com/device/K014114
Methodology: https://510kreport.com/methodology