Maximus System— 510(k) K192143
Substantially EquivalentHill-Rom Services Pte, Ltd.
FDA 510(k) clearance K192143 for Maximus System, Substantially Equivalent on 2020-02-14. Applicant: Hill-Rom Services Pte, Ltd.. Device class: 2.
Clearance details
- Applicant
- Hill-Rom Services Pte, Ltd.
- Product code
- Code NHJ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5905
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Singapore, SG
Recent devices under product code NHJ
view allMore clearances from Hill-Rom Services Pte, Ltd.
view allAdverse events under product code NHJ
product code NHJ- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K192143
K-number listed on FDA's recall record- Z-2548-2026 — Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
- Z-2549-2026 — Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number REF M08270; Oscillation Lung Expansion Therapy, positive pressure breathing device
- Z-2550-2026 — Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number REF M08473; Oscillation Lung Expansion Therapy, positive pressure breathing device
- Z-2551-2026 — Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog Number REF M08474; Oscillation Lung Expansion Therapy, positive pressure breathing device
- Z-1637-2026 — Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
- Z-2321-2024 — Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.
- Z-2322-2024 — Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K192143.
Data sourced from openFDA. This site is unofficial and independent of the FDA.