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ANI Monitor

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K142969

by MDoloris Medical Systems SAS

Identifiers

510(k) Number
K142969 FDA 510(k)
FDA Product Code
DPS FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2340 FDA 510(k)
Regulation Number
870.2340 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The ANI Monitor V2 is a Class IIa medical device classified as a Patient Monitor (Device Type: DPS) designed for continuous monitoring of nociception and patient comfort. It assesses the balance between nociceptive (pain) and antinociceptive (pain-relieving) processes by analyzing heart rate variability and sympatho-vagal balance, providing an objective metric for clinical assessment.

The device is intended for use in clinical settings where patient comfort and pain management are critical, such as intraoperative and postoperative care. Supplied as a reusable medical instrument, it requires appropriate sterilization and maintenance per manufacturer guidelines. Authorized under FDA 510K and MDR, the ANI Monitor V2 adheres to regulatory standards for cardiovascular monitoring devices, with no specific MRI safety restrictions noted.

Frequently asked questions

What clinical scenarios is the ANI Monitor V2 primarily designed to support, and how does it help in those settings?

The ANI Monitor V2 is specifically designed for intraoperative and postoperative care, where managing patient comfort and pain is critical. It provides continuous monitoring of nociception by analyzing heart rate variability and sympatho-vagal balance, offering an objective metric to assess the balance between pain signals and pain-relieving responses. This helps clinicians make data-driven decisions to optimize analgesia, reduce opioid use, and improve patient recovery outcomes.

Is the ANI Monitor V2 a single-use or reusable device, and what maintenance or sterilization requirements apply?

The ANI Monitor V2 is supplied as a reusable medical instrument, meaning it is intended for repeated use across multiple patients. Like all reusable devices, it must undergo proper sterilization and maintenance procedures as outlined by the manufacturer to ensure safety, functionality, and compliance with regulatory standards. Always follow the manufacturer’s guidelines for cleaning, sterilization, and servicing.

What regulatory pathways does the ANI Monitor V2 follow, and how does this affect its use in clinical settings?

The ANI Monitor V2 is authorized under both the FDA 510K pathway (traditional clearance, classified as substantially equivalent under product code DPS) and the EU MDR (Medical Device Regulation). This means it meets U.S. and European regulatory standards for cardiovascular monitoring devices, ensuring its safety, performance, and compliance with applicable guidelines. Clinicians can rely on its regulatory approvals when integrating it into intraoperative or postoperative workflows.

Does the ANI Monitor V2 have any restrictions on use in environments with MRI machines?

The device’s specifications do not mention any MRI safety restrictions, meaning it is not explicitly labeled as MRI-safe or MRI-conditional. However, since it is a reusable medical instrument for cardiovascular monitoring, its use near MRI environments should follow standard electromagnetic interference (EMI) precautions. Always verify compatibility with your facility’s MRI protocols and consult the manufacturer for guidance if MRI exposure is a concern.

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: ANI patient monitor - ANI MONITOR V2 - Mdoloris Medical Systems ..., MDOLORIS ANI MONITOR V2 USER MANUAL Pdf Download, Patient Monitor for Nociception ANI Monitor V2 - MDoloris Medical ..., MDOLORIS ANI MONITOR V2 USER MANUAL Pdf Download

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
MDoloris Medical Systems SAS

Sources (2)

  • FDA 510(k) K142969 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026