510(k) Report

Devices descending from K861593

11 later devices reach Topical Hyperbaric Oxygen Chamber through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K971507O2 BOOTGwr Medical, Llp199710—
+2K080966Hyper-Box Topical Wound Oxygen SystemAoti, Ltd.20082—
+2K023456Oxybox SystemOxyfast Corporation200342
+2K022028VX-400 Topical Hyperbaric Oxygen ChamberVascular One, Inc.20024—
+3K212121VHT-200 Wound Treatment SystemVaporox, Inc.20231—
+3K112634Natrox Topical Oxygen Delivery System with IodpInotec Amd, Ltd.20120—
+3K120764Epiflo (R)Neogenix, LLC20121—
+3K090681Tanscu O2Electrochemical Oxygen Concepts, Inc.20091—
+3K050156WHS-1000 Wound Healing SystemIyia Technologies, Inc.20050—
+4K250188Wound Treatment System (VHT-200)Vaporox, Inc.20250—
+4K190742Epiflo-28Neogenix, LLC Dba Ogenix20190—