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)
Top companies in NHJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Baxter Healthcare Corporation | 0 | 10 |
| Percussionaire Corp. | 2 | 7 |
| Abmrc, LLC | 4 | 0 |
| Hill-Rom Services Pte, Ltd. | 4 | 0 |
| Dima Italia Srl | 3 | 0 |
| Vortran Medical Technology 1, Inc. | 3 | 0 |
| J. H. Emerson Co. | 2 | 0 |
| Lung Assist, Inc. | 2 | 0 |
| Breas Medical AB | 1 | 0 |
| Comedica , Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2026 | Percussionaire Corporation Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HC Open, Classified |
NHJ | None listed |
| Sep 28, 2026 | Percussionaire Corporation Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction Manual Open, Classified |
NHJ | None listed |
| Sep 28, 2026 | Percussionaire Corporation Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with Instruction Manual Open, Classified |
NHJ | None listed |
| Sep 28, 2026 | Percussionaire Corporation Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual Open, Classified |
NHJ | None listed |
| Sep 28, 2026 | Percussionaire Corporation Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Phasitron 5, Product Number: P5 used with Instruction Manual Open, Classified |
NHJ | None listed |
| Sep 28, 2026 | Percussionaire 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 |
NHJ | None listed |
| Sep 23, 2026 | Baxter 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 |
NHJ | K200988 |
| Jul 1, 2026 | Baxter 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 |
NHJ | K192143 K200988 |
| Jul 1, 2026 | Baxter 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 |
NHJ | K192143 K200988 |
| Jul 1, 2026 | Baxter 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 |
NHJ | K192143 K200988 |
| Jul 1, 2026 | Baxter 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 |
NHJ | K192143 K200988 |
| Apr 1, 2026 | Baxter Healthcare Corporation Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system. Open, Classified |
NHJ | K192143 K200988 |
| Oct 30, 2024 | Percussionaire Corporation Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy Open, Classified |
NHJ | K905236 |
| Jul 17, 2024 | Baxter Healthcare Corporation Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component. Open, Classified |
NHJ | K192143 K200988 |
| Jul 17, 2024 | Baxter 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 |
NHJ | K192143 K200988 |
| May 30, 2022 | Baxter Healthcare Corporation In-Line ventilator adaptor Terminated |
NHJ | K200988 |
| May 30, 2022 | Baxter Healthcare Corporation In-Line ventilator adaptor Terminated |
NHJ | K200988 |
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