Cleared Traditional

K964648 - PROTECT ALL BLOOD PRESSURE CUFF COVER

K964648 is an FDA 510(k) clearance for PROTECT ALL BLOOD PRESSURE CUFF COVER, manufactured by Protect All, Inc.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K964648 · Protect All, Inc. · Cardiovascular device
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Feb 1997
Decision
90d
Days
Class 2
Risk

K964648 is an FDA 510(k) clearance for the PROTECT ALL BLOOD PRESSURE CUFF COVER. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Protect All, Inc. (Piedmont, US). The FDA issued a Cleared decision on February 18, 1997 after a review of 90 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 Protect All, Inc. devices

FDA 510(k) Submission Details - K964648

510(k) Number K964648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1996
Decision Date February 18, 1997
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 106
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K964648.
SANAPHON N
K972378 · Rudolf Riester GmbH & Co. KG · Sep 1997
PRECISA N
K972379 · Rudolf Riester GmbH & Co. KG · Sep 1997
BIG BEN SQUARE, BIG BEN ROUND
K972301 · Rudolf Riester GmbH & Co. KG · Sep 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