510(k) K200988 ยท NHJ Device, Positive Pressure Breathing, Intermittent
Maximus System
| Applicant | Hill-Rom Services Pte, Ltd., Singapore, SG |
| Decision | Substantially Equivalent, May 26, 2020 |
| Received | Apr 15, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200988
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Jul 17, 2024 | Baxter Healthcare Corporation Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component. Open, Classified |
NHJ | None listed |
| May 30, 2022 | Baxter Healthcare Corporation In-Line ventilator adaptor Terminated |
NHJ | None listed |
| May 30, 2022 | Baxter Healthcare Corporation In-Line ventilator adaptor Terminated |
NHJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.