# K191490: Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Caina Medical Co.,Ltd
- Decided: Oct 3, 2019 after 120 days
- Product code: MEG (Syringe, Antistick)
- 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: 4 generations back to K000572 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980069: Vanishpoint Syringe, Retractable Technologies, Inc. (1998) Summary page 4.
- K031594: Bak'snap Duopro Safety Syring (Duopross) Safety'tray Allergy Safety Syringe Tray, M.K. Meditech Co., Ltd. (2003) Summary page 4.
- K132681: Sol-Guard Insulin and Tuberculin Safety Syringe, Sol-Millennium Medical, Inc. (2014) Summary page 4.

## Indications for use
The Retractable Safety Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe plunge, the syringe user is protected from accidental needle sticks. These accidental needle sticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container. For general injection use: The function of Retractable Safety Syringe is to provide a safe and reliable method of injecting fluids into or withdrawing fluids from the body. The Retractable Safety Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse. The syringe contains various capacity, such as 1ml, 2.5ml, 3ml, 5ml and 10ml. For allergy use: The 1ml Retractable Safety Allergy Syringe is intended for the preparation/mixing of allergenic extracts/prescribed substances, the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. The Retractable Safety Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse. For Tuberculin use: The 1ml Retractable Safety Tuberculin Syringe is intended for the delivery of Tuberculin. The Retractable Safety Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse.

Source page: https://510kreport.com/device/K191490
Methodology: https://510kreport.com/methodology