Device class
—
Regulation —
Total clearances
5
2024-07-08 → 2026-04-21
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
RhythMedix, LLC |
2 |
1 |
2026-04-21 |
|
Smartcardia SA |
1 |
0 |
2024-10-31 |
|
VivaQuant, Inc. |
1 |
0 |
2025-07-11 |
|
iRhythm Technologies, Inc.
|
1 |
0 |
2024-10-21 |
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 93228 |
CPT
|
— |
High
|
Electrocardiogram, continuous (ambulatory) monitoring and analysis with report |
| 93229 |
CPT
|
— |
High
|
Electrocardiographic monitoring, outpatient, extended (24+ hours) |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-04-21 |
K250793 |
RhythMedix, LLC
|
RhythmStar System (SL) |
| 2025-07-11 |
K241179 |
VivaQuant, Inc.
|
Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) |
| 2024-10-31 |
K240653 |
Smartcardia SA
|
SmartCardia 7L Platform (MCT) |
| 2024-10-21 |
K240029 |
iRhythm Technologies, Inc.
|
Zio AT® device (A100A1001) |
| 2024-07-08 |
K233584 |
RhythMedix, LLC
|
RhythmStar System |