# K233794: Insulin Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Spm Medicare Pvt., Ltd.
- Decided: Mar 6, 2024 after 99 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: 6 generations back to K931367 (1993). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223453: Insulin Syringe, Promisemed Hangzhou Meditech Co., Ltd. (2023) Summary page 5.

## Indications for use
The sterile Insulin Syringe is for single use, with the calibrated unit of insulin for U-40 & U-100. The Insulin Syringe is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface of the skin. The device is intended to be used for adults only.

Source page: https://510kreport.com/device/K233794
Methodology: https://510kreport.com/methodology