Cleared Traditional

K823843 - FREEMAN ACETABULAR CUP

K823843 is an FDA 510(k) clearance for FREEMAN ACETABULAR CUP, manufactured by Depuy, Inc.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K823843 · Depuy, Inc. · Cardiovascular device
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Mar 1983
Decision
98d
Days
Class 2
Risk

K823843 is an FDA 510(k) clearance for the FREEMAN ACETABULAR CUP. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Depuy, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 29, 1983 after a review of 98 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 Depuy, Inc. devices

FDA 510(k) Submission Details - K823843

510(k) Number K823843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1982
Decision Date March 29, 1983
Days to Decision 98 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 125d · This submission: 98d
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 145
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K823843.
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
AUFRANC-TURNER ATS METAL BACKED ACETABU
K830097 · Howmedica Corp. · Jan 1983
ONE HAND ANEROID SPHYGMOMANOMETER
K821232 · Abco Dealers, Inc. · May 1982
RELIEVED REINFORCED CUP
K820539 · Biomet, Inc. · Mar 1982