# K171131: MHC Standard and NRFit Tip Syringes

- Pathway: 510(k) (Traditional)
- Applicant: Mazza Healthcare, LLC
- Decided: Nov 8, 2017 after 205 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). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170218: Vesco Medical NRFit Tip Syringes, Vesco Medical, LLC (2017) Summary page 4.
- K103736: DMC Medical Single-Use Polycarbonate Syringe, Dmc Medical, Ltd. (2011) Summary page 4.

## Most influential descendants
- K212764: Medwell Technology Ltd Syringes, various sizes (2022), 0 descendants of its own

## Indications for use
The MHC Standard and NRFitTM Tip Syringes are intended to inject fluids into or withdraw fluids from the body.

Source page: https://510kreport.com/device/K171131
Methodology: https://510kreport.com/methodology