Identity
- Trade Name
- QuantaFlo FDA UDI
- Generic Name
- Limb plethysmograph FDA UDI
- Device Name
- USB Sensor FDA UDI
- Model / Reference
- 91-0010 FDA UDI
- Description
- USB Sensor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859433006024 FDA UDI
- 510(k) Number
- FDA Product Code
- JOM FDA 510(k)FDA UDI
- GMDN Term
- Limb plethysmograph FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.2780 FDA 510(k)
- Regulation Number
- 870.2780 FDA 510(k)FDA UDI
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
The QuantaFlo PAD Photoelectric Plethysmograph is a pneumatic, photoelectric device used for detecting Peripheral Arterial Disease (PAD). Classified as a plethysmograph, it measures blood flow and vascular function in the lower extremities to assess arterial health and identify early signs of PAD.
This device is intended for use in clinical or home settings and operates as a non-invasive, point-of-care tool. Supplied as a reusable medical instrument, it adheres to FDA 510(k) clearance under the classification of Device Class II (regulation number 870.2780). It requires proper calibration and maintenance in accordance with manufacturer guidelines to ensure accurate and reliable performance.
Frequently asked questions
What clinical conditions is the QuantaFlo designed to evaluate in patients?
The QuantaFlo is specifically designed to detect and assess Peripheral Arterial Disease (PAD) by measuring blood flow and vascular function in the lower extremities. It helps identify early signs of arterial health issues in this region through non-invasive, point-of-care testing.
Is the QuantaFlo intended for use in both clinical and home settings, and how does that affect its design?
Yes, the QuantaFlo is approved for use in both clinical and home settings as a non-invasive, point-of-care tool. Its design prioritizes ease of use, portability, and reliability to accommodate different environments while ensuring accurate vascular function assessment.
How is the QuantaFlo supplied, and does it require any special handling or maintenance?
The QuantaFlo is supplied as a reusable medical instrument, meaning it is not single-use. Proper calibration and maintenance are required to ensure its accuracy and reliability, as outlined in the manufacturer’s guidelines.
What regulatory pathway was followed for FDA clearance of the QuantaFlo, and what does that mean for its classification?
The QuantaFlo received FDA clearance through a 510(k) submission, classified as Device Class II under regulation number 870.2780. This means it was determined to be substantially equivalent to a legally marketed predicate device and is subject to additional controls beyond general controls due to its higher risk classification.
Are there multiple models or sizes of the QuantaFlo, and how would a buyer determine which one to select?
The QuantaFlo is associated with multiple registration numbers and product codes (e.g., JOM), which may correspond to different models or configurations. While the data does not specify exact size variations, buyers should consult the manufacturer’s documentation or contact Semler Scientific for guidance on selecting the appropriate model based on their clinical or home-use needs.
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: QuantaFlo PAD | Semler Scientific, Inc., Semler | Semler Scientific, Inc., Office of Public Affairs | Semler Scientific Inc. and Bard Peripheral ..., QuantaFlo<sup>®</sup> PAD - Physicians Office Resource
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K143094 | Class II | Active |
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Manufacturer
- Manufacturer
- Semler Scientific, Inc.
Sources (2)
- FDA 510(k) K143094 24 fields · synced Sep 18, 2026
- FDA UDI 1a5031b8-9df4-4849-b5f3-65c3a9843abd 35 fields · synced May 27, 2026