# K252033: Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle

- Pathway: 510(k) (Traditional)
- Applicant: CMT Health PTE., Ltd.
- Decided: Jul 25, 2025 after 25 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: 7 generations back to K931367 (1993). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211211: Sterile syringes for single use with/without needle, Azur Medical Company, Inc. (2021) Summary page 5.

## Indications for use
The ProfojectTM Disposable Syringe and the ProfojectTM Disposable Syringe with Needle are intended to be used for medical purposes to inject fluid into or withdraw fluid from body.

Source page: https://510kreport.com/device/K252033
Methodology: https://510kreport.com/methodology