CPRmeter 2 CPR Feedback Device
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K173886 FDA 510(k)
- FDA Product Code
- LIX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5210 FDA 510(k)
- Regulation Number
- 870.5210 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CPRmeter 2 CPR Feedback Device is a Cardiopulmonary Resuscitation Aid designed to provide real-time feedback during chest compressions. It monitors compression rate, depth, and recoil to ensure optimal performance during resuscitation efforts, adhering to clinical guidelines for effective CPR delivery.
This device is intended for use in emergency medical settings, including pre-hospital and in-hospital environments, and is supplied as a reusable medical aid. It operates independently of MRI compatibility concerns and is regulated under the Medical Device Directive (MDD) and FDA 510(k) clearance (K173886) as a Class II device. Storage and maintenance instructions are specified in the manufacturer’s documentation.
Frequently asked questions
What specific metrics does the CPRmeter 2 monitor during chest compressions to ensure effective CPR delivery?
The CPRmeter 2 monitors compression rate, depth, and recoil in real-time to guide rescuers toward optimal performance. These metrics align with clinical guidelines for CPR, helping maintain consistent pressure and rhythm during resuscitation efforts.
Is the CPRmeter 2 designed for single-use or reusable applications, and how should it be maintained?
The CPRmeter 2 is explicitly described as a reusable medical aid. Maintenance and storage instructions are detailed in the manufacturer’s documentation, which should be consulted for proper cleaning, calibration, and long-term care to ensure continued accuracy and functionality.
Does the CPRmeter 2 have any restrictions on use in environments with MRI equipment?
No, the CPRmeter 2 is independent of MRI compatibility concerns, meaning it can be used safely in settings where MRI machines are present without interference or risk.
What regulatory pathways has the CPRmeter 2 followed, and what classification does it hold?
The CPRmeter 2 has received FDA 510(k) clearance (K173886) under the Traditional pathway, classified as a Class II device. It is also authorized under the Medical Device Directive (MDD). The device was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K173886 | Class II | Active |
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Manufacturer
- Manufacturer
- Laerdal Medical AS
Sources (2)
- FDA 510(k) K173886 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026