# K193526: Syringe with safety needle, Safety needle

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Caina Medical Co.,Ltd
- Decided: Jul 17, 2020 after 211 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: 7 generations back to K771205 (1977). 18 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170651: Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle, Yangzhou Medline Industry, Co., Ltd. (2017) Summary page 6.

## Most influential descendants
- K211329: Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle (2021), 3 descendants of its own
- K232950: Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle (2024), 1 descendant of its own
- 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
- K213054: Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe (2022), 0 descendants of its own
- K221073: Sterile Hypodermic Syringes for Single Use with Safety Needles (2022), 0 descendants of its own

## Indications for use
The Syringe with Safety Needle is intended for use in the aspiration and injection of fluids for medical purpose. 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 needle stick. The Safety Needle is intended for use with a luer lock syringe for aspiration and injection of fluids for medical purpose. 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 needle stick.

Source page: https://510kreport.com/device/K193526
Methodology: https://510kreport.com/methodology