510(k) Report

Devices descending from K003035

4 later devices reach Clarren Helmet through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070694Ccro (Craniocephalic Custom Remolding Orthosis)Mike Miner20070—
+1K023572Loma Linda University Medical Center (Llumc) Cranial Remolding HelmetRehabilitation Institute,Loma Linda University Med20031—
+1K022273Cranial Symmetry SystemBeverly Hills Prosthetics Orthotics, Inc.20020—
+1K012007RHS HelmetRestorative Health Svs, Inc.20010—