510(k) Report

Devices descending from K052397

3 later devices reach Careo Safety Syringe (3CC/ML, 5CC/ML, 10CC/ML) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060208Careo Safety Syringe 1CC/ML, Models…Life-Shield Products, Inc.20062—
+2K061055Careo Safety Syringe for U-100 InsulinLife-Shield Products, Inc.20061—
+3K072037Careo Safety Syringe for U-100 Insulin 0.5CC/MLLife-Shield Products, Inc.20070—