# K070936: Welmed Hypodermic Syringe

- Pathway: 510(k) (Abbreviated)
- Applicant: Welmed, Inc.
- Decided: Jul 16, 2007 after 104 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: 2 generations back to K980580 (1998). 2 ancestors in all.
88 later devices descend from it; 5 cite it directly.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024052: Merit Medical 1-ML Syringe, Merit Medical Systems, Inc. (2003) Summary page 1.

## Most influential descendants
- K072739: Jierui Syringes and Needles (2008), 78 descendants of its own
- K110421: Disposable Insulin Syringe (2011), 36 descendants of its own
- K112057: KDL Syringes and Needle (2011), 31 descendants of its own
- K190002: Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use (2019), 13 descendants of its own
- K180417: Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use (2018), 12 descendants of its own

## Indications for use
The intended use of the Welmed, Inc. piston syringes is to inject fluids into or withdraw fluids from the body.

Source page: https://510kreport.com/device/K070936
Methodology: https://510kreport.com/methodology