Cleared Traditional

POROCOAT SCHATZKER II ACETABULUM (K852193) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K852193 · Depuy, Inc. · Cardiovascular device
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Jul 1985
Decision
71d
Days
Class 2
Risk

K852193 is an FDA 510(k) clearance for the POROCOAT SCHATZKER II ACETABULUM. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 30, 1985 after a review of 71 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 Depuy, Inc. devices

Submission Details

510(k) Number K852193 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 20, 1985
Decision Date July 30, 1985
Days to Decision 71 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
54d faster than avg
Panel avg: 125d · This submission: 71d
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 43
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K852193.
ADULT,STERILE,DISPOS.,NONIVAS.,BLOOD PRESS. CUFFS
K905147 · Hewlett-Packard Co. · Dec 1990
NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF
K905101 · Hewlett-Packard Co. · Dec 1990
HEWLETT-PACKARD SERIES OF DISPOSABLE NIBP CUFFS
K901252 · Hewlett-Packard Co. · Jul 1990
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