510(k) Report

Devices descending from K153537

5 later devices reach Sol-M Insulin Syringe, Sol-M TB Syringe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220713Sol-Guard Auto-disable SyringeSol-Millennium Medical, Inc.20230—
+1K211242Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic SyringesPromisemed Hangzhou Meditech Co., Ltd.20213—
+2K213560Verifine Safety Syringe with Fixed NeedlePromisemed Hangzhou Meditech Co., Ltd.20222—
+3K231792VeriSafe Safety sterile syringesPromisemed Hangzhou Meditech Co., Ltd.20231—
+4K250192Verisafe Safety Retractable Insulin SyringesPromisemed Hangzhou Meditech Co., Ltd.20250—