NOxBOXi Nitric Oxide Delivery System— 510(k) K171696
Substantially EquivalentPraxair Distribution, Inc.
FDA 510(k) clearance K171696 for NOxBOXi Nitric Oxide Delivery System, Substantially Equivalent on 2018-10-02. Applicant: Praxair Distribution, Inc.. Device class: 2.
Clearance details
- Applicant
- Praxair Distribution, Inc.
- Product code
- Code MRN
- Device class
- Class 2
- Regulation
- 21 CFR 868.5165
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Danbury, CT, US
Recent devices under product code MRN
view allAdverse events under product code MRN
product code MRN- Death
- 9
- Malfunction
- 910
- Total
- 919
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 K171696
K-number listed on FDA's recall record- Z-0028-2026 — NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
- Z-0029-2026 — NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
- Z-2544-2025 — NOxBOXi Nitric Oxide Delivery System
- Z-1667-2023 — NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171696.
Data sourced from openFDA. This site is unofficial and independent of the FDA.