Cleared Traditional

K801303 - MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST

K801303 is the FDA 510(k) clearance for MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST by Western Laboratories Corp.. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K801303 · Western Laboratories Corp. · Gastroenterology & Urology device
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Jul 1980
Decision
55d
Days
Class 2
Risk

K801303 is an FDA 510(k) clearance for the MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TEST. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Western Laboratories Corp. (Mchenry, US). The FDA issued a Cleared decision on July 28, 1980 after a review of 55 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 Western Laboratories Corp. devices

Submission Details

510(k) Number K801303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1980
Decision Date July 28, 1980
Days to Decision 55 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 130d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 199
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K801303.
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K790827 · Hospal Medical Corp. · Sep 1979
CORTRAL I
K780527 · Hospal Medical Corp. · Dec 1978
HEMODIALYZER, MODEL RP610, RP AN 69
K781464 · Hospal Medical Corp. · Dec 1978