# K253068: Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe

- Pathway: 510(k) (Traditional)
- Applicant: CMT Health PTE., Ltd.
- Decided: Feb 23, 2026 after 154 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). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 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 6.
- K061492: Monoject Magellan Insulin and Tuberculin Safety Syringe, Tyco Healthcare (2006) Summary page 6.

## Indications for use
Profoject™ Insulin Syringes (Model A): The Profoject™ Insulin Syringes are intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes. Profoject™ Insulin Syringes (Model B): The Profoject™ Insulin Syringes are intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes. Profoject™ Safelock Disposable Insulin Syringe The device is intended for the delivery of U-40 or U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.

Source page: https://510kreport.com/device/K253068
Methodology: https://510kreport.com/methodology