# K231856: TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))

- Pathway: 510(k) (Traditional)
- Applicant: Medexel Co.,Ltd
- Decided: Mar 15, 2024 after 266 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.
1 later device descends from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213010: FEELject LDV (Low dead volume) syringe, Feeltech Co., Ltd. (2023) Summary page 5.

## Most influential descendants
- K252814: Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead Space Syringe with Needle /Profoject™ Tuberculin Syringe with Needle; Profoject™ Low Dead Space Syringe with Permanent Needle /Profoject™ Tuberculin Syringe with Permanent Needle;  Profoject™ Low Dead Space Safety Syringe /Profoject™ Tuberculin Safety Syringe (2026), 0 descendants of its own

## Indications for use
TopFine® LDS (Low Dead Space) Syringe is intended for use to inject fluid into or withdraw fluids from the parts of body below the surface of the skin.

Source page: https://510kreport.com/device/K231856
Methodology: https://510kreport.com/methodology