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Reusable NIBP Cuff

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K173197

by Orantech Inc.

Identifiers

510(k) Number
K173197 FDA 510(k)
FDA Product Code
DXQ 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)

This device is a Reusable Non-Invasive Blood Pressure (NIBP) Cuff, classified under the FDA’s product code DXQ for cardiovascular monitoring. It is designed to measure systolic and diastolic blood pressure and pulse rate in adult patients via oscillometric technology, providing continuous or intermittent readings in clinical or home settings.

The cuff is supplied as a single-tube, large adult size with an integrated inflation bag and a bladderless design, covering a range of 31–53 cm arm circumference. Manufactured from durable TPU materials, it is intended for reusable clinical use and must be cleaned and disinfected between patients. Authorized under FDA 510(k) clearance (K173197) and MDR compliance, it adheres to regulatory standards for reusable blood pressure measurement devices.

Frequently asked questions

Is this cuff designed for single-use or reusable in clinical settings, and what cleaning requirements apply?

This cuff is explicitly designed for reusable clinical use and must be cleaned and disinfected between patients. It is manufactured from durable TPU materials, which are suitable for repeated sterilization and maintenance. Proper cleaning ensures accuracy and hygiene, as required for continuous or intermittent blood pressure monitoring in adult patients.

What arm circumference range does this cuff accommodate, and is it suitable for all adult patients?

The cuff covers arm circumferences between 31–53 cm, making it appropriate for most adult patients. However, patients with significantly larger or smaller arms may require a different size to ensure accurate blood pressure readings, as the bladderless design relies on proper fit for oscillometric measurement.

How is this cuff supplied, and does it include any additional components for use?

The cuff is supplied as a single-tube, large adult size with an integrated inflation bag. It does not include a blood pressure monitor—it is intended to pair with compatible oscillometric devices for systolic, diastolic, and pulse rate measurements in clinical or home settings.

What regulatory pathways does this device follow, and how does that affect its use?

The cuff is authorized under FDA 510(k) clearance (K173197) and MDR compliance, confirming it meets regulatory standards for reusable blood pressure measurement devices. This means it adheres to safety and performance requirements for cardiovascular monitoring (product code DXQ) and can be legally marketed and used in the U.S. and EU under these authorizations.

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: Orantech Inc. BP-80BS Reusable NIBP Cuff - RevMed, Orantech Inc. BP-70BS Reusable NIBP Cuff, Orantech - Reusable Cuffs, K173197 FDA 510 (k) - Reusable NIBP Cuff | Orantech, Inc.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Orantech Inc.
FDA Applicant
Orantech, Inc.

Sources (2)

  • FDA 510(k) K173197 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026