# K252098: PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)

- Pathway: 510(k) (Traditional)
- Applicant: Methyl Co., Ltd.
- Decided: Feb 18, 2026 after 230 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: 6 generations back to K904198 (1990). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113422: Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with Safety Needle, Terumo (Philippines) Corporation (2012) Summary page 5.

## Indications for use
This product is designed for medical applications, specifically to administer injections or extract body fluids. It can be used to inject drug solutions into tissues or aspirate body fluids. To prevent the possibility of needle pricks, the safety device can be engaged to secure the injection needle within a removable outer sleeve.

Source page: https://510kreport.com/device/K252098
Methodology: https://510kreport.com/methodology