Veridian Corp
Veridian Pulse Monitor (VPM-4000 Series)
510(k) Number: K240847
Continuous heart rate and cardiac rhythm monitoring system for use in hospital, clinic, and ambulatory care settings.
510(k) Clearance Summary
| Field | Value |
|---|---|
| Submitter | Veridian Corp, 1200 Innovation Drive, San Francisco, CA 94107 |
| Contact | Dr. Elena Vasquez, VP Regulatory Affairs — e.vasquez@veridian-corp.com |
| Device Name | Veridian Pulse Monitor, VPM-4000 Series |
| 510(k) Number | K240847 |
| Decision Date | March 14, 2024 |
| Decision | Substantially Equivalent (SE) |
| Product Code | DRT — Electrocardiograph |
| Regulation Number | 21 CFR 870.2340 |
| Predicate Device | CardioTrack Pro Monitor (510(k) K193847) |
| Review Panel | Cardiovascular |
| Review Time | 87 days |
The Veridian Pulse Monitor VPM-4000 is indicated for continuous monitoring and display of heart rate and cardiac rhythm in adult patients in clinical settings.
The device must not be used as the sole basis for diagnosis; all arrhythmia alerts require clinician verification.
Wireless telemetry data transmission must comply with IEC 60601-1-2 EMC requirements and use AES-256 encryption.
Software updates to the VPM-4000 firmware require validation per SOP-SW-002 before deployment to marketed devices.
Download: 510(k) Summary PDF (K240847)
Technical Specifications
| Parameter | Specification | Test Method | Acceptance Criteria |
|---|---|---|---|
| Heart Rate Range | 30–250 bpm | IEC 60601-2-27 | ±2 bpm or ±2% |
| ECG Lead Configuration | 3-lead, 5-lead | Design verification | Per IFU Section 4.2 |
| Battery Life | 72 hours continuous | IEC 60601-1 | ≥ 68 hours minimum |
| Wireless Protocol | Bluetooth 5.0 LE, Wi-Fi 802.11ac | FCC Part 15, IEC 60601-1-2 | Pass all EMC tests |
| Display | 7" touchscreen LCD | Visual inspection | Readable at 1 meter |
| Operating Temperature | 10°C to 40°C | IEC 60601-1 | Functional at extremes |
| IP Rating | IP44 | IEC 60529 | Pass ingress test |
| Software Version (cleared) | VPM-FW-4.2.1 | Software validation | Per DHF-240847-SW |
Post-Market Requirements
All VPM-4000 device complaints must be logged in the complaint management system within 24 hours of receipt.
Annual post-market surveillance reports for K240847 must be submitted to FDA by March 31 each year.
Field safety corrective actions for VPM-4000 require CISO and Regulatory Affairs joint approval before implementation.
Known Adverse Event Categories (MAUDE-Compatible)
| Event Type | Reportable | MDR Timeline | 2025 Count |
|---|---|---|---|
| False arrhythmia alert | Yes, if serious injury | 30 days | 3 |
| Electrode skin irritation | Yes, if requiring medical intervention | 30 days | 7 |
| Wireless connectivity loss | No (malfunction only if causes harm) | 30 days if reportable | 12 |
| Battery failure | Yes, if monitoring interrupted during critical care | 5 days if remedial action needed | 1 |