# K231907: Medline Safety Insulin and TB Syringes

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, LP
- Decided: Oct 18, 2023 after 111 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: 2 generations back to K922522 (1992). 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)
- K061492: Monoject Magellan Insulin and Tuberculin Safety Syringe, Tyco Healthcare (2006) Summary page 4.

## Indications for use
The Medline Safety Insulin Syringe is intended for the delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks. The Medline TB (Tuberculin) Syringe is intended for the delivery of tuberculin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.

Source page: https://510kreport.com/device/K231907
Methodology: https://510kreport.com/methodology