# K230235: Medline Luer Lock Syringes

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, LP
- Decided: Feb 16, 2024 after 385 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: 2 generations back to K980987 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182589: BD Plastipak Syringe, Becton, Dickinson and Company (2019) Summary page 4.

## Indications for use
Medline Luer-Lock Syringes are intended for use by healthcare professionals for general purpose fluid aspiration/injection. Intended for manual use.

Source page: https://510kreport.com/device/K230235
Methodology: https://510kreport.com/methodology