# K061055: Careo Safety Syringe for U-100 Insulin

- Pathway: 510(k) (Abbreviated)
- Applicant: Life-Shield Products, Inc.
- Decided: Jul 10, 2006 after 84 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: 4 generations back to K012121 (2001). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050134: Icc Insulin Safepro Safety Syringe, Formosa Medical Devices, Inc. (2005) Summary page 1.
- K060208: Careo Safety Syringe 1CC/ML, Models CA0106-C,CA0196-C,CA0186-C,CA0107-C,CA0197-C,CA0187-C,CA0104-C,CA0194-C,CA0184-C,, Life-Shield Products, Inc. (2006) Summary page 1.

## Most influential descendants
- K072037: Careo Safety Syringe for U-100 Insulin 0.5CC/ML (2007), 0 descendants of its own

## Indications for use
The CAREO Safety Syringe for U-100 Insulin 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 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/K061055
Methodology: https://510kreport.com/methodology