HemoSphere Nano Monitor (HSNANO1)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K253186 FDA 510(k)
- FDA Product Code
- DQK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1425 FDA 510(k)
- Regulation Number
- 870.1425 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The HemoSphere Nano Monitor (HSNANO1) is a cardiovascular device designed to monitor patient blood pressure and hemodynamic parameters continuously. It operates in conjunction with a compatible cuff to provide real-time data for individualized patient care.
Supplied as a reusable monitor, it is intended for use in clinical settings and is authorized under FDA 510(k) clearance (K253186) with product code DQK. The device is manufactured by Edwards Lifesciences, LLC and was cleared on February 24, 2026, following a traditional review process.
Frequently asked questions
What is the HemoSphere Nano Monitor (HSNANO1) used for?
The HemoSphere Nano Monitor (HSNANO1) is designed to continuously monitor patient blood pressure and hemodynamic parameters in clinical settings. It works with a compatible cuff to provide real-time data, enabling individualized patient care by tracking cardiovascular status over time.
Is the HemoSphere Nano Monitor (HSNANO1) reusable or single-use?
The HemoSphere Nano Monitor (HSNANO1) is supplied as a reusable monitor, meaning it is intended for multiple uses after proper cleaning and disinfection between patients, in accordance with the manufacturer’s instructions for clinical environments.
What regulatory authorization does the HemoSphere Nano Monitor (HSNANO1) have?
The HemoSphere Nano Monitor (HSNANO1) is authorized under FDA 510(k) clearance (K253186) with product code DQK. It was cleared on February 24, 2026, following a traditional review process and found substantially equivalent to a predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Edwards HemoSphere Nano Monitor Operator's Manual, PDF HemoSphere Nano_clean - eifu.edwards.com, Edwards HSNANO1 Manuals | ManualsLib, HemoSphere Nano Monitor (HSNANO1) (K253186) — FDA 510 (k) | Innolitics, Edwards Lifesciences HemoSphere Nano Monitor (hsnano1)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253186 | Class II | Active |
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Manufacturer
- Manufacturer
- Edwards Lifesciences LLC
- FDA Applicant
- Edwards Lifesciences, LLC
Sources (1)
- FDA 510(k) K253186 24 fields · synced Oct 6, 2026