Cleared Traditional

ULTRACUFF BLOOD PRESSURE CUFF AND INFLATION BAG (K954282) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K954282 · Statcorp, Inc. · Cardiovascular device
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Feb 1996
Decision
146d
Days
Class 2
Risk

K954282 is an FDA 510(k) clearance for the ULTRACUFF BLOOD PRESSURE CUFF AND INFLATION BAG. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Statcorp, Inc. (Franklin, US). The FDA issued a Cleared decision on February 6, 1996 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1120 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Statcorp, Inc. devices

Submission Details

510(k) Number K954282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1995
Decision Date February 06, 1996
Days to Decision 146 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 125d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXQ Blood Pressure Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1120
Definition A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXQ Blood Pressure Cuff

All 197
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K954282.
YP-710T Series NIBP Cuff
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NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722)
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K250765 · Avita Corporation · Sep 2025
Disposable Neonatal NIBP Cuff (U1682S-C51N)
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