# K250138: Small Volume 0.2mL Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Prosum Medical Limited
- Decided: Apr 2, 2025 after 75 days
- Product code: QNQ (Low Dead Space Piston Syringe)
- 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: 9 generations back to K771205 (1977). 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)
- K210443: PLPT LDV (Low Dead Volume) Sterile Syringe, Poonglim Pharmatech, Inc. (2021) Summary page 5.

## Indications for use
The Small Volume 0.2mL Syringe is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.

Source page: https://510kreport.com/device/K250138
Methodology: https://510kreport.com/methodology