# K232950: Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle

- Pathway: 510(k) (Traditional)
- Applicant: Perfect Medical Industry (Vn) Co., Ltd.
- Decided: Jun 12, 2024 after 266 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: 9 generations back to K771205 (1977). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211329: Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle, Jiangsu Kangbao Medical Equipment Co., Ltd. (2021) Summary page 5.

## Most influential descendants
- K251089: EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Syringe with Secure Touch® Safety Needle; EXEL Disposable Hypodermic Needle (2025), 0 descendants of its own

## Indications for use
Sterile Disposable Syringe is intended to be used to withdraw solutions and insert solutions into patient’s body. Sterile Disposable Syringe with needle are intended to be used with a luer slip or luer lock syringe to withdraw solutions and insert solutions into patient’s body. Sterile Disposable Syringe with safety needle is intended to be used with a luer slip or luer lock syringe to withdraw solutions and insert solutions into patient’s body. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.

Source page: https://510kreport.com/device/K232950
Methodology: https://510kreport.com/methodology