510(k) Report

Devices descending from K052798

2 later devices reach Capsuls, Models 2003-PUR8C, 2004-PVC8C through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231256Carecube Negative Pressure Isolation ChamberCarecubes, Inc.20240—
+1K163223ORCA (tm) - Operational Rescue Containment ApparatusIsovac Products, LLC20170—