ClearanceBrief
Panels › Anesthesiology › Product code NHJ · Class 2

Device, Positive Pressure Breathing, Intermittent

Regulation 868.5905

2510(k)s in 12 months (26 all time)
12recalls in 12 months (17 all time)
11recalls that name a 510(k)
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Top companies in NHJ

Company510(k)sRecalls
Baxter Healthcare Corporation010
Percussionaire Corp.27
Abmrc, LLC40
Hill-Rom Services Pte, Ltd.40
Dima Italia Srl30
Vortran Medical Technology 1, Inc.30
J. H. Emerson Co.20
Lung Assist, Inc.20
Breas Medical AB10
Comedica , Inc.10
DateFirm and productCodeLinked 510(k)
Sep 28, 2026Percussionaire Corporation
Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC
Open, Classified
NHJNone listed
Sep 28, 2026Percussionaire Corporation
Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction Manual
Open, Classified
NHJNone listed
Sep 28, 2026Percussionaire Corporation
Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual
Open, Classified
NHJNone listed
Sep 28, 2026Percussionaire Corporation
Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual
Open, Classified
NHJNone listed
Sep 28, 2026Percussionaire Corporation
Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual
Open, Classified
NHJNone listed
Sep 28, 2026Percussionaire Corporation
Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; Phasitron 5 Breathing Circuit with Unified Connector, Product Number: P5-UC, used with In-Line Valve Instruction Manual
Open, Classified
NHJNone listed
Sep 23, 2026Baxter Healthcare Corporation
Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, HOMECARE, NORTH AMERICA Component: No
Open, Classified
NHJK200988
Jul 1, 2026Baxter Healthcare Corporation
Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
Open, Classified
NHJK192143
K200988
Jul 1, 2026Baxter Healthcare Corporation
Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device
Open, Classified
NHJK192143
K200988
Jul 1, 2026Baxter Healthcare Corporation
Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
Open, Classified
NHJK192143
K200988
Jul 1, 2026Baxter Healthcare Corporation
Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
Open, Classified
NHJK192143
K200988
Apr 1, 2026Baxter Healthcare Corporation
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
Open, Classified
NHJK192143
K200988
Oct 30, 2024Percussionaire Corporation
Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
Open, Classified
NHJK905236
Jul 17, 2024Baxter Healthcare Corporation
Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.
Open, Classified
NHJK192143
K200988
Jul 17, 2024Baxter Healthcare Corporation
Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.
Open, Classified
NHJK192143
K200988
May 30, 2022Baxter Healthcare Corporation
In-Line ventilator adaptor
Terminated
NHJK200988
May 30, 2022Baxter Healthcare Corporation
In-Line ventilator adaptor
Terminated
NHJK200988

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