FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System
K Number: K182245
·
Decision Nov 30, 2018
Classifications
1
FEI Numbers
428
Registration Numbers
428
Same Product Code
1216
Applicant Total
136
Review Days
102
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System
- K Number
- K182245
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Edwards Lifesciences, LLC
- Date Received
- August 20, 2018
- Decision Date
- November 30, 2018
- Product Code
- DXN
- 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXN), ordered by most recent decision date.
Wrist Blood Pressure Monitor (XW-05)
FDA 510(k)
FDA Class 2
·Cardiovascular
VicorderCS (VCS-SYS-1100)
FDA 510(k)
FDA Class 2
·Cardiovascular
Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08)
FDA 510(k)
FDA Class 2
·Cardiovascular
Upper arm electronic blood pressure monitor (XB-01)
FDA 510(k)
FDA Class 2
·Cardiovascular
Blood Pressure Monitor (W06LT)
FDA 510(k)
FDA Class 2
·Cardiovascular
Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T)
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 |
| K253186 | HemoSphere Nano Monitor (HSNANO1) | Feb 24, 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 |