Device class
Class II
Regulation 870.2850
Total clearances
3
2023-03-17 → 2026-09-10
Classification details
Medical specialty
Cardiovascular
Regulation number
870.2850
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Edwards Lifesciences, LLC
|
1 |
0 |
2025-03-21 |
|
Merit Medical Pte. , Ltd. |
1 |
0 |
2023-03-17 |
|
Procerus Enterprises |
1 |
1 |
2026-09-10 |
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 |
| 93000 |
CPT
|
— |
Medium
|
Electrocardiogram monitoring often bundles with transducer use; blood pressure transducers support cardiovascular monitoring |
| A4326 |
HCPCS
|
Male external catheter with integral collection chamber, any type, each ✓ CMS-verified description |
Medium
|
HCPCS supply code for blood pressure transducers and sensors |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-09-10 |
K254074 |
Procerus Enterprises
|
TruPress |
| 2025-03-21 |
K242909 |
Edwards Lifesciences, LLC
|
FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors |
| 2023-03-17 |
K221782 |
Merit Medical Pte. , Ltd.
|
Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes |