510(k) Report

Devices descending from K052198

6 later devices reach Relieva Sinus Balloon Inflation Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K150172ACCLARENT SE Inflation DeviceAcclarent, Inc.20150—
+1K090660Airway Balloon Catheter Inflation DeviceAcclarent, Inc.200947
+2K231818METIC™- Airway Balloon CatheterM/S Meril Life Sciences Pvt., Ltd.20230—
+2K153484Dillard Airway Dilatation SystemIntuit Medical Products, LLC20160—
+2K150951aeris Balloon Dialation CatheterBryan Medical, Inc.201511
+2K110218Inspira Air Balloon Dilation SystemAcclarent, Inc.201109