Identifiers
- 510(k) Number
- K882118 FDA 510(k)
- FDA Product Code
- DRS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2850 FDA 510(k)
- Regulation Number
- 870.2850 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Model 700 Patient Monitor is a Transducer, Blood-Pressure, Extravascular designed for continuous non-invasive monitoring of blood pressure and related cardiovascular parameters. It provides real-time physiological data, supporting clinical assessments in critical care and procedural settings where precise hemodynamic tracking is required.
This device is intended for use in clinical environments, supplied as a reusable medical instrument with no specified sterility requirements. It is classified as a Class II device under FDA regulations (870.2850) and holds an FDA 510(k) clearance (K882118) for substantial equivalence in the cardiovascular specialty. No MRI safety classification or specific storage conditions are noted in the regulatory data.
Frequently asked questions
What clinical settings is the Model 700 Patient Monitor designed for, and what specific data does it provide?
The Model 700 Patient Monitor is designed for continuous non-invasive monitoring of blood pressure and related cardiovascular parameters in clinical environments. It is particularly suited for critical care and procedural settings where real-time hemodynamic tracking is essential. The device provides physiological data such as blood pressure trends, which supports clinical assessments in high-acuity areas like intensive care units, operating rooms, or emergency departments.
Is the Model 700 Patient Monitor intended for single-use or reusable applications, and what are the sterility requirements?
The Model 700 Patient Monitor is supplied as a reusable medical instrument and does not have specified sterility requirements in the regulatory data. This means it is designed for repeated use in clinical settings, but proper cleaning and maintenance protocols must be followed to ensure safety and functionality between patient encounters.
What regulatory pathway was followed for FDA clearance of the Model 700 Patient Monitor, and what does this mean for its intended use?
The Model 700 Patient Monitor received FDA 510(k) clearance (K882118) under the traditional review pathway, demonstrating substantial equivalence to a predicate device. This clearance was granted through the Cardiovascular (CV) Advisory Committee, confirming its classification as a Class II device (870.2850) for extravascular blood-pressure monitoring. The clearance does not define clinical indications but confirms the device’s compliance with FDA standards for non-invasive hemodynamic monitoring.
Are there any special storage conditions or MRI safety considerations for the Model 700 Patient Monitor?
The regulatory data for the Model 700 Patient Monitor does not specify any unique storage conditions or MRI safety classifications. This means standard environmental storage practices (e.g., protected from extreme temperatures or physical damage) should suffice. However, since it is a reusable device, adherence to manufacturer guidelines for cleaning and maintenance is critical to ensure reliable performance.
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: K882118 FDA 510 (k) - MODEL 700 PATIENT MONITOR, Ivy Biomedical Systems, Inc. Welcome, MODEL 700 PATIENT MONITOR (K882118) — FDA 510(k) | Innolitics, Ivy Biomedical Systems, Inc. Device Database
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K882118 | Class II | Active |
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Manufacturer
- Manufacturer
- Ivy Biomedical Systems, Inc.
Sources (1)
- FDA 510(k) K882118 24 fields · synced Sep 20, 2026