# K221981: SafeR Syringe and SafeR Sting

- Pathway: 510(k) (Traditional)
- Applicant: Roncadelle Operations Srl
- Decided: Dec 29, 2022 after 177 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: 3 generations back to K980069 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132120: WTF Secura Syringe and Needle, Beijing Wantefu Medical Apparatus Co., Ltd. (2013) Summary page 4.

## Indications for use
SafeR® is an automatically Retractable Safety Syringe, it is intended to provide a safe, accurate and reliable method for the aspiration of fluids and for the injection of fluids immediately after filling. It is intended to be used for the administration of medications (intramuscular (IM), intradermal (ID) and subcutaneous (SC)). SafeR® system is provided in 2 separate parts: SafeR Syringe and the needle group SafeR Sting. Before use, the end user needs to assemble syringe and needle group. The syringe, once assembled with his needle, incorporates a passive safety mechanism which retracts and contains the contaminated needle after use, aiding in prevention of possible infection due to needlestick injuries and syringe re-use. Needle retraction is activated by the syringe user with one hand. SafeR Sting blunt fill needle is designed only for drug preparation and it is not intended to come in contact with human body. SafeR Syringe with SafeR Sting maintain standard injection techniques.

Source page: https://510kreport.com/device/K221981
Methodology: https://510kreport.com/methodology