# K052445: Duopross Needle

- Pathway: 510(k) (Traditional)
- Applicant: Duopross Meditech Corporation
- Decided: Dec 5, 2005 after 89 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K771203 (1977). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K771203: Disp. Hypodermic Needle, Terumo America, Inc. (1977) Summary page 2.

## Most influential descendants
- K112777: Sol-M Exchangeable Needles (2012), 0 descendants of its own

## Indications for use
The DuoProSS Needle device is a sterile hypodermic needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

Source page: https://510kreport.com/device/K052445
Methodology: https://510kreport.com/methodology