# K212764: Medwell Technology Ltd Syringes, various sizes

- Pathway: 510(k) (Traditional)
- Applicant: Medwell Technology, Ltd.
- Decided: Nov 4, 2022 after 430 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: 8 generations back to K931367 (1993). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171131: MHC Standard and NRFit Tip Syringes, Mazza Healthcare, LLC (2017) Summary page 4.

## Indications for use
The Medwell Technology Polycarbonate Syringes are intended to inject fluids into or withdraw fluids from the body.

Source page: https://510kreport.com/device/K212764
Methodology: https://510kreport.com/methodology