510(k) Report

Devices descending from K991685

11 later devices reach Halolite Aad System with Dedicated Compressor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042991I-Neb Aad SystemProfile Therapeutics Plc20056—
+1K030747Prodose Aad SystemProfile Therapeutics Plc200410—
+2K102454I-Neb Aad System with Tim; I-Neb Insight Aad SystemRespironics Respiratory Drug Delivery (Uk), Ltd.20110—
+2K100380Altera Nebulizer System, Model 678G1002Pari Respiratory Equipment, Inc.20104—
+2K072019AKITA2 ApixnebActivaero America, Inc.20073—
+3K142059Fox MobileVectura GmbH20150—
+3K112859Erapid Nebulizer SystemPari Respiratory Equipment, Inc.20123—
+3K090730Akita JetActivaero America, Inc.20090—
+4K223840eRapid Nebulizer SystemPari Respiratory Equipment, Inc.20231—
+4K162785Velox Nebulizer SystemPari Respiratory Equipment, Inc.20170—
+5K251572eRapid with eTrack SystemPari Respiratory Equipment, Inc.20250—