Cleared Traditional

K831001 - UNICUFF-BLOOD PRESSURE CUFF

K831001 is an FDA 510(k) clearance for UNICUFF-BLOOD PRESSURE CUFF, manufactured by Frontier Products. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K831001 · Frontier Products · Cardiovascular device
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Jul 1983
Decision
121d
Days
Class 2
Risk

K831001 is an FDA 510(k) clearance for the UNICUFF-BLOOD PRESSURE CUFF. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Frontier Products (Mchenry, US). The FDA issued a Cleared decision on July 28, 1983 after a review of 121 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 Frontier Products devices

FDA 510(k) Submission Details - K831001

510(k) Number K831001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1983
Decision Date July 28, 1983
Days to Decision 121 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 125d · This submission: 121d
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 149
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K831001.
P.C.A. TOTAL HIP FEMORAL COMPONENT MODIFICATION
K852964 · Howmedica Corp. · Jul 1985
HOMEDICA CEMENTED ACETABULAR COMPONENT 6262
K851565 · Howmedica Corp. · Jul 1985
ETHOX NEONATAL BLOOD PRESSURE CUFF-STERILE/DISPOS.
K844988 · Ethox Corp. · Apr 1985
VASCULAB BLOOD PRESSURE CUFF
K831393 · Medasonics, Inc. · Jun 1983
METAL-BACKED ACETABULAR CUP
K831479 · Dow Corning Corp. Healthcare Industries Materials · Jun 1983
FREEMAN ACETABULAR CUP
K823843 · Depuy, Inc. · Mar 1983