# K103736: DMC Medical Single-Use Polycarbonate Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Dmc Medical, Ltd.
- Decided: Jun 10, 2011 after 170 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: 3 generations back to K980580 (1998). 3 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070856: Icu Medical Single-Use Syringe, Icu Medical, Inc. (2007) Summary page 1.

## Most influential descendants
- K171131: MHC Standard and NRFit Tip Syringes (2017), 1 descendant of its own
- K223678: Sterile Syringes for Single Use (2023), 0 descendants of its own
- K212764: Medwell Technology Ltd Syringes, various sizes (2022), 0 descendants of its own
- K161812: Freedom Syringe (2017), 0 descendants of its own

## Indications for use
DMC Medical piston type syringes are single use syringes intended for injecting fluids into or withdrawing fluids from the body.

Source page: https://510kreport.com/device/K103736
Methodology: https://510kreport.com/methodology