# K203211: Insulin syringe with integrated needle DL

- Pathway: 510(k) (Traditional)
- Applicant: Dlp Medical Products, Corp.
- Decided: Feb 9, 2023 after 832 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: 5 generations back to K931367 (1993). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162180: Disposable Insulin Syringe, Berpu Medical Technology Co., Ltd. (2016) Summary page 4.

## Indications for use
Disposable syringe for insulin administration, for the patient with diabetes

Source page: https://510kreport.com/device/K203211
Methodology: https://510kreport.com/methodology