Cleared Traditional

K853333 - DIMENSION TOTAL HIP PROSTHESIS

K853333 is an FDA 510(k) clearance for DIMENSION TOTAL HIP PROSTHESIS, manufactured by Kirschner Medical Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KDI cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K853333 · Kirschner Medical Corp. · Gastroenterology & Urology device
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Sep 1985
Decision
26d
Days
Class 2
Risk

K853333 is an FDA 510(k) clearance for the DIMENSION TOTAL HIP PROSTHESIS. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Kirschner Medical Corp. (Timonium, US). The FDA issued a Cleared decision on September 3, 1985 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - the FDA gastroenterology and urology device 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 Kirschner Medical Corp. devices

FDA 510(k) Submission Details - K853333

510(k) Number K853333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1985
Decision Date September 03, 1985
Days to Decision 26 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 130d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDI Device Classification - Class 2, Special Controls

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 216
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K853333.
HOLLOW FIBER DIALYZER
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RENALFO HEMOFILTER CAVHD
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FILTRAL HEMODIALYZER
K852885 · Hospal Medical Corp. · Sep 1985
RENAFLO HEMOCONCENTRATOR
K844790 · Renal Systems, Inc. · May 1985
TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1L
K850866 · Erika, Inc. · Apr 1985
AMER. BENTLEY CONTINU-BLOOD PROCESSOR-
K841585 · American Bentley · Oct 1984