Identifiers
- 510(k) Number
- K193629 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)
The Disposable Non-Invasive Blood Pressure Cuff is a single-use medical device designed for measuring blood pressure without invasive procedures. Classified under the nomenclature for blood pressure measurement devices, it utilises a cuff-based oscillometric method to estimate systolic and diastolic pressure via arterial pulsations.
Supplied in single-use packaging, this cuff is intended for one-time clinical or veterinary use and must be discarded after use. Authorised under FDA 510(k) clearance (K193629) and MDR compliance, it is available in multiple sizes, including adult (25–35 cm) and veterinary variants. Non-woven material construction ensures sterility and hygiene, with no MRI safety restrictions specified.
Frequently asked questions
What sizes of the Disposable NIBP Cuff are available, and how do I know which one to choose for a patient or animal?
The Disposable NIBP Cuff comes in two primary sizes: adult (25–35 cm) and veterinary variants. The adult size is designed for human patients, while the veterinary variants are intended for animals. To select the correct size, measure the patient’s arm circumference—adult cuffs are appropriate for arms within the 25–35 cm range, and veterinary sizes should be chosen based on the animal’s specific limb dimensions as specified by the manufacturer’s guidelines.
Is the Disposable NIBP Cuff reusable, or is it meant for single-use only?
The Disposable NIBP Cuff is explicitly designed for single-use only. The packaging and non-woven material construction ensure sterility and hygiene, and the device must be discarded after one use to prevent contamination and maintain accuracy. Reusing it violates the manufacturer’s instructions and could compromise patient safety.
How should I store the Disposable NIBP Cuff before use, and what are the shelf-life considerations?
The cuff should be stored in its original, unopened packaging to preserve sterility and prevent contamination. The manufacturer does not specify a shelf-life in the provided data, but standard practices for disposable medical devices recommend adhering to the expiration date printed on the packaging. Always check for damage to the packaging before use, and avoid exposing the cuff to extreme temperatures or moisture.
Can this cuff be used in environments with MRI machines, or are there any safety restrictions?
The Disposable NIBP Cuff does not have any specified MRI safety restrictions mentioned in the provided data. However, since it is a disposable, non-metallic device, it is unlikely to interfere with MRI procedures. That said, always verify compatibility with your facility’s MRI protocols and ensure the cuff is removed before the patient enters the MRI scanner to avoid any potential issues.
What regulatory pathways does the Disposable NIBP Cuff follow, and how does that affect its use in clinical settings?
The Disposable NIBP Cuff is authorized under FDA 510(k) clearance (K193629) and MDR compliance, meaning it has undergone regulatory review to demonstrate substantial equivalence to legally marketed devices. This clearance allows its use in clinical and veterinary settings in the U.S. and EU, respectively. Clinicians should confirm local regulatory compliance and follow the manufacturer’s instructions for proper use and disposal.
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: Disposable NIBP Cuff (K193629) — FDA 510 (k) | Innolitics, NIBP Cuff_Changke Connect, Changke Connect
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K193629 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Changke Connect Electronics Co., Ltd.
Sources (2)
- FDA 510(k) K193629 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026