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

Name: FDA 510(k) clearance K253186
Creator: U.S. Food and Drug Administration
Published: 2026-02-24

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.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code DQK
Device class: Class 2
Regulation: 21 CFR 870.1425
Advisory panel: Cardiovascular
Date received: 2025-09-26
Decision date: 2026-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQK

view all

K253692 — AVVIGO+ Multi-Modality Guidance System2026-08-21
K262005 — Affera Integrated Mapping System2026-08-21
K253576 — CorVista System® with PCWP Add-On2026-07-26
K262006 — EnSite X EP System2026-07-15
K252978 — ScioCardio ECG Analysis Platform2026-07-09

More clearances from Edwards Lifesciences, LLC

view all

K251326 — Respiration Rate algorithm2026-06-11
K251982 — Edwards MC3 Tricuspid annuloplasty ring (4900)2025-09-23
K251688 — Carpentier-Edwards Physio Annuloplasty Ring (4450)2025-09-17
K242518 — Hypertension Prediction Index (HePI) Algorithm2025-05-15
K242909 — FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors2025-03-21

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, 2020-01-01 through 2026-04-23. 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.