Cleared Traditional

K951753 - MEDTEC AUTOBLOT 2000

K951753 is an FDA 510(k) clearance for MEDTEC AUTOBLOT 2000, manufactured by Medtec, Inc.. The device is a Class 1 Microbiology device with product code JQW cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K951753 · Medtec, Inc. · Microbiology device
Download Printable Device Report (PDF)
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Oct 1995
Decision
183d
Days
Class 1
Risk

K951753 is an FDA 510(k) clearance for the MEDTEC AUTOBLOT 2000. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Medtec, Inc. (Washington, US). The FDA issued a Cleared decision on October 17, 1995 after a review of 183 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.2750 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtec, Inc. devices

FDA 510(k) Submission Details - K951753

510(k) Number K951753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1995
Decision Date October 17, 1995
Days to Decision 183 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 102d · This submission: 183d
Pathway characteristics
Predicate-based equivalence.

JQW Device Classification - Class 1, General Controls

Product Code JQW Station, Pipetting And Diluting, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2750
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 - JQW Station, Pipetting And Diluting, For Clinical Use

All 83
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K951753.
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IMPACT
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