# K243806: Safety Winged Blood Collection Sets

- Pathway: 510(k) (Special)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: Jan 10, 2025 after 30 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: 6 generations back to K912563 (1991). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211293: Safety Winged Blood Collection Sets, Promisemed Hangzhou Meditech Co., Ltd. (2021) Summary page 5.

## Indications for use
The safety winged blood collection set is single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The device is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The blood-collection needle is designed to be covered with a safety mechanism, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury.

Source page: https://510kreport.com/device/K243806
Methodology: https://510kreport.com/methodology