Cleared Traditional

K962655 - ANEROID AND MERCURIAL SPHYGMOMANOMETERS

K962655 is the FDA 510(k) clearance for ANEROID AND MERCURIAL SPHYGMOMANOMETERS by American Diagnostic Corp.. It is a Class 2 Cardiovascular device (product code DXQ) cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K962655 · American Diagnostic Corp. · Cardiovascular device
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Jan 1997
Decision
203d
Days
Class 2
Risk

K962655 is an FDA 510(k) clearance for the ANEROID AND MERCURIAL SPHYGMOMANOMETERS. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by American Diagnostic Corp. (West Babylon, US). The FDA issued a Cleared decision on January 27, 1997 after a review of 203 days - an extended review cycle.

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 American Diagnostic Corp. devices

Submission Details

510(k) Number K962655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1996
Decision Date January 27, 1997
Days to Decision 203 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
78d slower than avg
Panel avg: 125d · This submission: 203d
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 69
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K962655.
CLEEN-ABLE
K994044 · Vital Signs, Inc. · Feb 2000
CUFF-ABLE PLUS
K990412 · Vital Signs, Inc. · Sep 1999
DEROYAL STERILE NEONATAL BLOOD PRESSURE CUFF
K991525 · Deroyal Industries, Inc. · Jul 1999
DEROYAL INDUSTRIS, INC. BLOOD PRESSURE CUFF
K953952 · Deroyal Industries, Inc. · Sep 1995
HAND ANEROID SPHYGMOMANOMETER
K940493 · Welch Allyn, Inc. · Jul 1994
BLOOD PRESSURE CUFFS
K912638 · Vital Signs, Inc. · Jul 1991