DeviceClearance

HemoSphere Nano Monitor (HSNANO1)— 510(k) K253186

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K253186 for HemoSphere Nano Monitor (HSNANO1), Substantially Equivalent on 2026-02-24. Applicant: Edwards Lifesciences, LLC. Device class: 2.

Summary

Edwards Lifesciences' HemoSphere Nano Monitor (HSNANO1) is filed under product code DQK (Computer, Diagnostic, Programmable). The record doesn't describe the monitor beyond its name and that code name.

Class II, 21 CFR 870.1425. Cardiovascular is both the classification panel and the review panel. It came in as a Traditional 510(k).

Edwards Lifesciences filed from Irvine, California. Review took 151 calendar days (September 26, 2025 to February 24, 2026), ending in a substantially equivalent decision.

Clearance details

Applicant
Edwards Lifesciences, LLC
Product code
Product code DQK
Device class
Class 2
Regulation
21 CFR 870.1425
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Irvine, CA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code DQK

product code DQK
Death
10
Injury
225
Malfunction
2,123
Other
2
Total
2,360

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.