FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HemoSphere Nano Monitor (HSNANO1)
K Number: K253186
·
Decision Feb 24, 2026
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
136
Review Days
151
Basic Information
- Device Name
- HemoSphere Nano Monitor (HSNANO1)
- K Number
- K253186
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Edwards Lifesciences, LLC
- Date Received
- September 26, 2025
- Decision Date
- February 24, 2026
- Product Code
- DQK
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQK), ordered by most recent decision date.
OneStim-DUO Cardiac Stimulator (MP5003-4CO)
FDA 510(k)
FDA Class 2
·Cardiovascular
Intra-Operative Positioning System (IOPS) (MC-1);IOPS Viewpoint Simple Curve Catheter, 75cm (C00751);IOPS Viewpoint Simple Curve Catheter, 125cm (C01251);IOPS Viewpoint Double Curve Catheter, 75cm (C00752);IOPS Viewpoint Double Curve Catheter, 125cm (C02152);IOPS Guidewire 2 (ATW-2);IOPS Fiducial Tracking Pad (T02111);IOPS Guidewire Handle (H01035)
FDA 510(k)
FDA Class 2
·Cardiovascular
ZEUS Platform (FG0501US)
FDA 510(k)
FDA Class 2
·Cardiovascular
EnSite X EP System
FDA 510(k)
FDA Class 2
·Cardiovascular
ACORYS MAPPING SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Synchrony
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Edwards Lifesciences, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K251326 | Respiration Rate algorithm | Jun 11, 2026 | Substantially Equivalent |
| K251982 | Edwards MC3 Tricuspid annuloplasty ring (4900) | Sep 23, 2025 | Substantially Equivalent |
| K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450) | Sep 17, 2025 | Substantially Equivalent |
| K242518 | Hypertension Prediction Index (HePI) Algorithm | May 15, 2025 | Substantially Equivalent |
| K242909 | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors | Mar 21, 2025 | Substantially Equivalent |
| K240078 | Fogarty Thru-Lumen Embolectomy Catheter | Aug 28, 2024 | Substantially Equivalent |
| K233984 | Acumen Assisted Fluid Management (AFM) Software Feature | Aug 2, 2024 | Substantially Equivalent |
| K233824 | Swan-Ganz catheter | Jun 6, 2024 | Substantially Equivalent |
| K233819 | Fogarty Venous Thrombectomy Catheters | May 22, 2024 | Substantially Equivalent |
| K230612 | Edwards Algorithm for Measurement of Blood Hemoglobin | Nov 17, 2023 | Substantially Equivalent |