Biomedix Padnet Lab
FDA 510(k)Class II (US FDA 510(k))
by Biomedix-Inc
Identifiers
- 510(k) Number
- K042616 FDA 510(k)
- FDA Product Code
- JOM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2780 FDA 510(k)
- Regulation Number
- 870.2780 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Biomedix Padnet Lab is a photoelectric, pneumatic or hydraulic plethysmograph designed for non-invasive assessment of peripheral vascular function. It measures arterial and venous blood flow dynamics, including ankle-brachial index (ABI) and toe-brachial index (TBI), to aid in the diagnosis of peripheral artery disease (PAD) and venous reflux disease.
This device is supplied as a portable, non-invasive system intended for use in clinical or office settings. It is intended for single-use or reusable components as specified in the manufacturer’s instructions, with no explicit mention of sterility requirements in the provided data. The system operates within MRI-safe parameters for its designated use and includes multiple registration numbers under FDA 510(k) clearance (K042616) for cardiovascular applications. Storage and handling follow standard medical device protocols as outlined in the user manual.
Frequently asked questions
What clinical conditions is the Biomedix Padnet Lab primarily used to evaluate?
The Biomedix Padnet Lab is designed for non-invasive assessment of peripheral vascular function, specifically to measure arterial and venous blood flow dynamics. It aids in diagnosing peripheral artery disease (PAD) and venous reflux disease by evaluating metrics like the ankle-brachial index (ABI) and toe-brachial index (TBI).
Is the Biomedix Padnet Lab suitable for use in an MRI environment?
Yes, the Biomedix Padnet Lab is designed to operate within MRI-safe parameters for its designated use, allowing it to be safely used in clinical settings where MRI scans are performed.
How is the Biomedix Padnet Lab supplied, and can its components be reused?
The Biomedix Padnet Lab is supplied as a portable, non-invasive system intended for use in clinical or office settings. Whether components are single-use or reusable depends on the manufacturer’s instructions, which should be followed to ensure proper use and safety.
What regulatory pathway was followed for FDA clearance of the Biomedix Padnet Lab?
The Biomedix Padnet Lab received FDA clearance through a 510(k) submission, specifically under the traditional review pathway. It was determined to be substantially equivalent to a predicate device and falls under the Cardiovascular (CV) advisory committee category, with a product code of JOM.
Does the Biomedix Padnet Lab require any special storage or handling instructions beyond standard medical device protocols?
The Biomedix Padnet Lab follows standard medical device protocols for storage and handling, as outlined in the user manual provided by the manufacturer. No additional details on specialized storage requirements are specified in the available data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PADnet - Biomedix, PADnet Details - Biomedix, BIOMEDIX PADNET USER MANUAL Pdf Download | ManualsLib, Biomedix Padnet Lab Non Invasive System Arterialvenous
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K042616 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomedix-Inc
- FDA Applicant
- Biomedix, Inc.
Sources (1)
- FDA 510(k) K042616 24 fields · synced Oct 6, 2026