FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KardiaAI
K Number: K201985
·
Decision Nov 12, 2020
Classifications
1
FEI Numbers
178
Registration Numbers
178
Same Product Code
429
Applicant Total
19
Review Days
118
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
- KardiaAI
- K Number
- K201985
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1425
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AliveCor, Inc.
- Date Received
- July 17, 2020
- Decision Date
- November 12, 2020
- 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 AliveCor, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252589 | Corvair Monza | Jan 9, 2026 | Substantially Equivalent |
| K231010 | Corvair | Jun 7, 2024 | Substantially Equivalent |
| K232035 | Impala | Jun 7, 2024 | Substantially Equivalent |
| K220350 | KardiaMobile 6L | May 25, 2022 | Substantially Equivalent |
| K212662 | AliveCor QT Service | Apr 26, 2022 | Substantially Equivalent |
| K211668 | KardiaMobile Card | Nov 30, 2021 | Substantially Equivalent |
| K210753 | KardiaMobile 6L | Jun 30, 2021 | Substantially Equivalent |
| K191406 | KardiaMobile, KardiaStation | Jan 24, 2020 | Substantially Equivalent |
| K183319 | Triangle System | May 10, 2019 | Substantially Equivalent |
| K182396 | KardiaMobile, KardiaStation | Apr 12, 2019 | Substantially Equivalent |