Ultracheck Curve Blood Pressure Cuffs
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K122365 FDA 510(k)
- FDA Product Code
- OED 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)
Ultracheck Curve Blood Pressure Cuffs are antimicrobial blood pressure cuffs intended for the non-invasive measurement of adult human blood pressure. They are designed for use by or under the supervision of qualified medical personnel.
These cuffs are reusable and supplied non-sterile. They are classified as Class II medical devices under FDA regulation 870.1120 with product code OED, and were cleared via the traditional 510(k) pathway (K122365) on June 4, 2013.
Frequently asked questions
What is the intended use of Ultracheck Curve Blood Pressure Cuffs?
Ultracheck Curve Blood Pressure Cuffs are intended for the non-invasive measurement of adult human blood pressure and are designed for use by or under the supervision of qualified medical personnel.
Are Ultracheck Curve Blood Pressure Cuffs sterile or non-sterile, and are they single-use or reusable?
These cuffs are supplied non-sterile and are designed to be reusable, allowing for multiple applications after appropriate cleaning between uses.
What regulatory pathway was used for the clearance of Ultracheck Curve Blood Pressure Cuffs, and what is their classification?
Ultracheck Curve Blood Pressure Cuffs were cleared via the traditional 510(k) pathway under K122365 and are classified as Class II medical devices under FDA regulation 870.1120 with product code OED.
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: UltraCheck Reusable Cuffs Archives - Spacelabs Healthcare, Amazon.com: blood pressure cuffs cuff bp ultracheck statcorp medical ..., ULTRACHECK CURVE BLOOD PRESSURE CUFFS (K122365) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122365 | Class II | Active |
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Manufacturer
- Manufacturer
- Statcorp Medical
Sources (1)
- FDA 510(k) K122365 24 fields · synced Sep 27, 2026