# K072037: Careo Safety Syringe for U-100 Insulin 0.5CC/ML

- Pathway: 510(k) (Special)
- Applicant: Life-Shield Products, Inc.
- Decided: Aug 8, 2007 after 14 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: 5 generations back to K000572 (2000). 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)
- K050131: Insosafe Bak'snap Retractable Insulin Safety Syringe, M.K. Meditech Co., Ltd. (2005) Summary page 1.
- K061055: Careo Safety Syringe for U-100 Insulin, Life-Shield Products, Inc. (2006) Summary page 1.

## Indications for use
The CAREO Safety Syringe for U-100 Insulin 0.5cc/mL is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for injection of insulin into a patient. The CAREO Safety Syringe for U-100 Insulin 0.5cc/mL is also intended to prevent needlestick injuries. In addition, when the user breaks the plunger, reuse of the syringe is prevented.

Source page: https://510kreport.com/device/K072037
Methodology: https://510kreport.com/methodology