Cleared Traditional

K954282 - ULTRACUFF BLOOD PRESSURE CUFF AND INFLATION BAG

K954282 is an FDA 510(k) clearance for ULTRACUFF BLOOD PRESSURE CUFF AND INFLA..., manufactured by Statcorp, Inc.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 146-day FDA review.

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

FDA 510(k) Submission Details - K954282

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
Combination Product No
PCCP Authorized No
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.

DXQ Device Classification - Class 2, Special Controls

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 132
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K954282.
CAMOUFLAGE CUFF SAVERS
K963987 · N.A. Braggs Medical, Inc. · Jul 1997
PROTECT ALL BLOOD PRESSURE CUFF COVER
K964648 · Protect All, Inc. · Feb 1997
ANEROID AND MERCURIAL SPHYGMOMANOMETERS
K962655 · American Diagnostic Corp. · Jan 1997
DEROYAL INDUSTRIS, INC. BLOOD PRESSURE CUFF
K953952 · Deroyal Industries, Inc. · Sep 1995
MINIMUS II
K942777 · Rudolf Riester GmbH & Co. KG · Jul 1994
HAND ANEROID SPHYGMOMANOMETER
K940493 · Welch Allyn, Inc. · Jul 1994