Cleared Traditional

K932752 - VISI-SPOT

K932752 is an FDA 510(k) clearance for VISI-SPOT, manufactured by J.S. Medical Assoc.. The device is a Class 1 Microbiology device with product code JTO cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K932752 · J.S. Medical Assoc. · Microbiology device
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Nov 1993
Decision
170d
Days
Class 1
Risk

K932752 is an FDA 510(k) clearance for the VISI-SPOT. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by J.S. Medical Assoc. (Natick, US). The FDA issued a Cleared decision on November 5, 1993 after a review of 170 days - an extended review 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: 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 J.S. Medical Assoc. devices

FDA 510(k) Submission Details - K932752

510(k) Number K932752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1993
Decision Date November 05, 1993
Days to Decision 170 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 102d · This submission: 170d
Pathway characteristics
Predicate-based equivalence.

JTO Device Classification - Class 1, General Controls

Product Code JTO Discs, Strips And Reagents, Microorganism Differentiation
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 - JTO Discs, Strips And Reagents, Microorganism Differentiation

All 196
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K932752.
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OXYSTRIP
K930693 · Hardy Diagnostics · May 1993