# K230287: SaviSafe Safety Device

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Savicred Biotechnology Co., Ltd.
- Decided: Nov 21, 2023 after 292 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 K011369 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123743: Ultrasafe Plus Passive Needle Guard, Safety Syringes, Inc. (2013) Summary page 5.

## Indications for use
The Savisafe Safety Device is indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.

Source page: https://510kreport.com/device/K230287
Methodology: https://510kreport.com/methodology