# K222925: Hypodermic Syringes & Needle

- Pathway: 510(k) (Traditional)
- Applicant: Lifelong Meditech Private Limited
- Decided: Jul 18, 2023 after 295 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: 6 generations back to K000572 (2000). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060211: Wuzhou Syringe, with/Without Needle, Wenzhou Wuzhou Group Co., Ltd. (2006) Summary page 6.
- K102584: Imc Hypodermic Needle, International Medsurg Connection (2011) Summary page 6.

## Indications for use
Sterile hypodermic single use syringe with needle or without needle: The Sterile Hypodermic syringe with needle or without needle is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body. Sterile hypodermic safety syringe (clip type) for single use with needle or without needle: The sterile hypodermic safety syringes for single use is intended to be used for medical purpose to inject fluids into or withdraw fluids from the body. After injection, the anti-needle stick feature is manually activated to aid in the prevention of accidental needle stick injuries. Sterile hypodermic safety syringes (needle retractable type) for single use with needle: The needle retractable safety syringe is to be used for intra-muscular or subcutaneous injection of medications into a patient and is intended to prevent needle stick injuries. Needle retractable safety syringe is not intended to be used for withdrawing blood. In addition, when the syringe user breaks the plunger, reuse of the syringe is prevented. Sterile hypodermic needle for single use: The Sterile Hypodermic needle intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.

Source page: https://510kreport.com/device/K222925
Methodology: https://510kreport.com/methodology