Cleared Traditional

K831479 - METAL-BACKED ACETABULAR CUP

K831479 is an FDA 510(k) clearance for METAL-BACKED ACETABULAR CUP, manufactured by Dow Corning Corp. Healthcare Industries Materials. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K831479 · Dow Corning Corp. Healthcare Industries Materials · Cardiovascular device
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Jun 1983
Decision
37d
Days
Class 2
Risk

K831479 is an FDA 510(k) clearance for the METAL-BACKED ACETABULAR CUP. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Dow Corning Corp. Healthcare Industries Materials (Walker, US). The FDA issued a Cleared decision on June 15, 1983 after a review of 37 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dow Corning Corp. Healthcare Industries Materials devices

FDA 510(k) Submission Details - K831479

510(k) Number K831479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1983
Decision Date June 15, 1983
Days to Decision 37 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
88d faster than avg
Panel avg: 125d · This submission: 37d
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 86
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K831479.
POROCOAT SCHATZKER II ACETABULUM
K852193 · Depuy, Inc. · Jul 1985
P.C.A. TOTAL HIP FEMORAL COMPONENT MODIFICATION
K852964 · Howmedica Corp. · Jul 1985
HOMEDICA CEMENTED ACETABULAR COMPONENT 6262
K851565 · Howmedica Corp. · Jul 1985
FREEMAN ACETABULAR CUP
K823843 · Depuy, Inc. · Mar 1983
AUFRANC-TURNER ATS METAL BACKED ACETABU
K830097 · Howmedica Corp. · Jan 1983
ONE HAND ANEROID SPHYGMOMANOMETER
K821232 · Abco Dealers, Inc. · May 1982