# K052397: Careo Safety Syringe (3CC/ML, 5CC/ML, 10CC/ML)

- Pathway: 510(k) (Traditional)
- Applicant: Life-Shield Products, Inc.
- Decided: Dec 22, 2005 after 113 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 K012121 (2001). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012726: Prosafe Safety Syringe, Hou-Se Medical, Inc. (2001)
- K012121: Secureguard Retractable Safety Syringe, Safegard Medical Products, Inc. (2001) Summary page 1.
- K030976: Careo Retractable Safety Syringe, Life-Shield Products, Inc. (2003) Summary page 1.

## Most influential descendants
- 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, (2006), 2 descendants of its own
- K061055: Careo Safety Syringe for U-100 Insulin (2006), 1 descendant of its own
- K072037: Careo Safety Syringe for U-100 Insulin 0.5CC/ML (2007), 0 descendants of its own

## Indications for use
The CAREO Safety Syringe is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient. The syringe should not be used for blood collection. The CAREO Safety Syringe aids in the prevention of needlestick injuries. In additional, when the user breaks the plunger, the CAREO Safety Syringe reduces the possibility of syringe reuse.

Source page: https://510kreport.com/device/K052397
Methodology: https://510kreport.com/methodology