Cleared Traditional

K853285 - MYWASHER 5

K853285 is the FDA 510(k) clearance for MYWASHER 5 by Scientific Sales Intl., Inc.. It is a Class 1 Microbiology device (product code LIB) cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K853285 · Scientific Sales Intl., Inc. · Microbiology device
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Oct 1985
Decision
60d
Days
Class 1
Risk

K853285 is an FDA 510(k) clearance for the MYWASHER 5. Classified as Device, General Purpose, Microbiology, Diagnostic (product code LIB), Class I - General Controls.

Submitted by Scientific Sales Intl., Inc. (Kalamazoo, US). The FDA issued a Cleared decision on October 4, 1985 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - the FDA microbiology 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 Scientific Sales Intl., Inc. devices

Submission Details

510(k) Number K853285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1985
Decision Date October 04, 1985
Days to Decision 60 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 102d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LIB Device, General Purpose, Microbiology, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LIB Device, General Purpose, Microbiology, Diagnostic

All 12
Devices cleared under the same product code (LIB) and FDA review panel - the closest regulatory comparables to K853285.
CORNING EASY WASH ELISA PLATES
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MICROSCOPE SLIDES
K862112 · Abco Dealers, Inc. · Jun 1986
READER MICROELISA SYSTEM
K831641 · Organon Teknika Corp. · Aug 1983
HEATING BLOCK MICROELISA SYSTEM
K831642 · Organon Teknika Corp. · Jul 1983
STRIPREADER MICROELISA SYSTEM
K831643 · Organon Teknika Corp. · Jul 1983