510(k) Report

Devices descending from K970010

15 later devices reach FPT Nebulizer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032849Aeroneb GO Nebulizer, Model AG-AG2000Aerogen, Inc.200311
+1K021175Aeroneb Professional Nebulizer System, Model#AG-AP6000Aerogen, Inc.200204
+1K992831Aeroneb II, Model Apn 200Aerogen, Inc.200011—
+2K162041Airworks Nebulizer pe1200mConvexity Scientific, LLC20170—
+2K033833Eflow Electronic Inhaler/NebulizerPari Innovative Manufacturers, Inc.200410—
+3K112859Erapid Nebulizer SystemPari Respiratory Equipment, Inc.20123—
+3K100380Altera Nebulizer System, Model 678G1002Pari Respiratory Equipment, Inc.20104—
+3K072670Modification to: Eflow Electronic Inhaler/NebulizerPari Innovative Manufacturers, Inc.20075—
+3K072019AKITA2 ApixnebActivaero America, Inc.20073—
+4K223840eRapid Nebulizer SystemPari Respiratory Equipment, Inc.20231—
+4K162785Velox Nebulizer SystemPari Respiratory Equipment, Inc.20170—
+4K142059Fox MobileVectura GmbH20150—
+4K102454I-Neb Aad System with Tim; I-Neb Insight Aad SystemRespironics Respiratory Drug Delivery (Uk), Ltd.20110—
+4K090730Akita JetActivaero America, Inc.20090—
+5K251572eRapid with eTrack SystemPari Respiratory Equipment, Inc.20250—