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Oscillomitt (Cm 1050 +4 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K000512

by Cas Medical Systems, Inc.

Identifiers

510(k) Number
K000512 FDA 510(k)
FDA Product Code
DXQ FDA 510(k)
Models / Variants
Cm 1050 FDA 510(k)
Cm 1040 FDA 510(k)
Cm 1030 FDA 510(k)
Cm 1020 FDA 510(k)
Cm 1010 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1120 FDA 510(k)
Regulation Number
870.1120 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Oscillomitt, Models CM 1050, CM 1040, CM 1030, CM 1020, CM 1010, is a cardiovascular monitoring device designed to measure and display oscillometric blood pressure. It employs an automated cuff inflation and deflation system to assess systolic, diastolic, and mean arterial pressure through indirect blood pressure measurement techniques.

These models are intended for use in clinical settings, including hospitals and critical care environments, where continuous or intermittent blood pressure monitoring is required. Supplied as reusable devices, they undergo regulatory review through the FDA’s 510(k) pathway, classified under product code DXQ and cleared as substantially equivalent to a predicate device. No specific sterility or MRI safety information is provided in the available data.

Frequently asked questions

What types of environments is the Oscillomitt designed for, and how does it differ from portable home-use monitors?

The Oscillomitt is specifically engineered for clinical settings like hospitals and critical care units where continuous or intermittent blood pressure monitoring is essential. Unlike home-use monitors, it is a reusable device built for professional use, featuring automated cuff inflation/deflation to measure systolic, diastolic, and mean arterial pressure via oscillometric technology. Its design prioritizes reliability in high-stakes environments where accuracy and durability are critical.

Are there different models of the Oscillomitt, and if so, how do they vary?

Yes, the Oscillomitt comes in five models: CM 1050, CM 1040, CM 1030, CM 1020, and CM 1010. While the exact differences between these models aren’t detailed in the specifications, the numbering suggests potential variations in features, performance, or intended clinical applications (e.g., advanced vs. basic monitoring). All models share the same core function of oscillometric blood pressure measurement in clinical settings.

How is the Oscillomitt supplied, and what does its reusable status mean for maintenance?

The Oscillomitt is supplied as a reusable device, meaning it is not single-use. This implies it is designed for repeated use across multiple patients, but it requires proper cleaning, disinfection, and maintenance between uses to ensure accuracy and hygiene. The manufacturer’s instructions (not provided here) would outline specific protocols for upkeep, as reusable devices in clinical settings must adhere to strict infection control standards.

What regulatory pathway was followed for the Oscillomitt, and what does this tell buyers about its approval?

The Oscillomitt was cleared through the FDA’s 510(k) pathway, specifically under product code DXQ and classified as substantially equivalent (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as an existing approved device, ensuring it meets regulatory standards for safety and effectiveness in measuring blood pressure. The clearance was granted by the Cardiovascular (CV) Advisory Committee in 2000.

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: Oscillomitt, Models Cm 1050, Cm 1040, Cm 1030, Cm 1020, Cm 1010 ..., OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010 by CAS ..., Oscillomitt, Models Cm 1050, Cm 1040, Cm 1030, Cm 1020, Cm 1010, PDF K000512 Oscillomitt, Models Cm 1050, Cm 1040, Cm 1030, Cm 1020, Cm 1010, Oscillomitt, Models Cm 1050, Cm 1040, Cm 1030, Cm 1020, Cm 1010

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cas Medical Systems, Inc.

Sources (1)

  • FDA 510(k) K000512 24 fields · synced Sep 19, 2026