Device class
Class II
Regulation 870.1435
Total clearances
5
2020-04-30 → 2026-02-13
Classification details
Medical specialty
Cardiovascular
Regulation number
870.1435
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Pulsion Medical Systems SE |
1 |
0 |
2020-04-30 |
|
Directed Systems, Ltd. |
1 |
0 |
2021-11-23 |
|
Retia Medical Systems, Inc. |
1 |
1 |
2026-02-13 |
|
Icu Medical
|
1 |
0 |
2023-12-20 |
|
Caretaker Medical
|
1 |
1 |
2025-09-26 |
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
|
— |
Low
|
Pre-programmed diagnostic computers are used to interpret ECG and other diagnostic data but lack dedicated billing code |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2026-02-13 |
K253092 |
Retia Medical Systems, Inc.
|
Argos Infinity (Rev. 1.0) |
| 2025-09-26 |
K251275 |
Caretaker Medical
|
VitalStream ART Connect; VitalStream-Hemo |
| 2023-12-20 |
K232048 |
Icu Medical
|
Cogent Hemodynamic Monitoring System; Cogent HMS |
| 2021-11-23 |
K212529 |
Directed Systems, Ltd.
|
Hypotension Decision Assist Model HDA-OR2 |
| 2020-04-30 |
K192169 |
Pulsion Medical Systems SE
|
PulsioFlex Monitoring System with ProAQT Sensor |