Model 404 Adult Heart Rate/Blood Pressure Monitor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K882188 FDA 510(k)
- FDA Product Code
- DXN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1130 FDA 510(k)
- Regulation Number
- 870.1130 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Model 404 Adult Heart Rate/Blood Pressure Monitor is a non-invasive cardiovascular monitoring device designed to simultaneously measure and display adult heart rate and blood pressure. It falls under the category of patient monitoring equipment, specifically for use in clinical settings where continuous or periodic assessment of vital signs is required. The device is intended for use in environments such as hospitals, diagnostic imaging centers, or emergency care facilities where accurate vital sign monitoring is critical for patient care.
This monitor is supplied as a reusable medical device and is intended for use in non-sterile settings, such as patient rooms or diagnostic suites. It is regulated under the FDA’s 510(k) clearance process, with a traditional review pathway and classified under product code DXN (Cardiovascular Monitoring Devices). The device requires proper calibration and maintenance as per manufacturer guidelines to ensure accurate readings. No specific MRI safety classification is stated, implying it is not intended for use within an MRI environment.
Frequently asked questions
Is the Model 404 designed for single-use or can it be reused in a clinical setting?
The Model 404 is explicitly labeled as a reusable medical device, meaning it is intended for repeated use in non-sterile environments like patient rooms or diagnostic suites. Since it is not sterile, it must be cleaned and maintained according to the manufacturer’s guidelines between uses to ensure accuracy and hygiene.
What types of clinical environments is this device intended for, and why?
The Model 404 is designed for clinical settings requiring continuous or periodic monitoring of adult heart rate and blood pressure, such as hospitals, diagnostic imaging centers, or emergency care facilities. Its non-invasive design and simultaneous measurement capabilities make it suitable for environments where real-time vital sign assessment is critical for patient care, such as during procedures or in intensive care units.
How is the regulatory pathway for this device structured, and what does that mean for buyers?
The Model 404 was cleared through the FDA’s 510(k) process with a traditional review pathway, meaning its safety and effectiveness were compared to a legally marketed predicate device. It falls under product code DXN (Cardiovascular Monitoring Devices) and was reviewed by the Cardiovascular (CV) Advisory Committee. Buyers should note this indicates compliance with U.S. regulatory standards for cardiovascular monitoring equipment, though they should verify the latest FDA status before purchasing.
Can this device be used inside an MRI environment, and why or why not?
The device does not have an explicit MRI safety classification listed in its specifications, which implies it is not intended for use within an MRI environment. Buyers should assume it may not be MRI-compatible unless confirmed otherwise by the manufacturer, as exposure to MRI fields could pose risks to both the device and patients.
What maintenance or calibration requirements should clinicians be aware of for accurate readings?
The Model 404 requires proper calibration and maintenance as outlined by Ivy Biomedical Systems to ensure accurate heart rate and blood pressure measurements. Clinicians should follow the manufacturer’s guidelines for routine checks, cleaning protocols (since it’s reusable), and any software updates to avoid drift in readings over time.
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: Ivy Operator Manuals - Ivy Biomedical Systems, Ivy Biomedical Systems, Inc. Device Database, Ivy Biomedical Systems User Manuals Download | ManualsLib, Ivy Biomedical Systems Blood Pressure Monitor User Manuals Download
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K882188 | Class II | Active |
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Manufacturer
- Manufacturer
- Ivy Biomedical Systems, Inc.
Sources (1)
- FDA 510(k) K882188 24 fields · synced Oct 6, 2026