510(k) Report

Devices descending from K980796

7 later devices reach Terumo Allergy Syringe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110456Pharmajet 0.1 ML Intradermal Needle-Free Injection SystemPharmajet, Inc.20111—
+1K092746Micronjet 600Nanopass Technologies, Ltd.20100—
+1K024249Terumo Surguard Safety SyringeTerumo Medical Corp.20033—
+2K121270Bioject Needle-Free Injection Management SystemBioject Medical Technologies, Inc.20120—
+2K072482Hypodermic Needle-Pro Safety Allergy TraySmiths Medical Asd, Inc.20070—
+2K063755Portex Hypodermic Needle-Pro Fixed Needle SyringeSmiths Medical Asd, Inc.20072Class I
+3K093176Med-LokSta-Med, LLC20100—