510(k) Report

Devices descending from K012726

5 later devices reach Prosafe Safety Syringe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052397Careo Safety Syringe (3CC/ML, 5CC/ML, 10CC/ML)Life-Shield Products, Inc.20053—
+1K031830Safepro Plus Safety SyringeFormosa Medical Devices, Inc.20030—
+2K060208Careo Safety Syringe 1CC/ML, Models…Life-Shield Products, Inc.20062—
+3K061055Careo Safety Syringe for U-100 InsulinLife-Shield Products, Inc.20061—
+4K072037Careo Safety Syringe for U-100 Insulin 0.5CC/MLLife-Shield Products, Inc.20070—