Cleared Traditional

K860617 - POLYPET

K860617 is the FDA 510(k) clearance for POLYPET by Instrumed, Inc.. It is a Class 1 Microbiology device (product code JTC) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K860617 · Instrumed, Inc. · Microbiology device
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Mar 1986
Decision
12d
Days
Class 1
Risk

K860617 is an FDA 510(k) clearance for the POLYPET. Classified as Device, Microtiter Diluting/dispensing (product code JTC), Class I - General Controls.

Submitted by Instrumed, Inc. (Union Bridge, US). The FDA issued a Cleared decision on March 3, 1986 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2500 - 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 Instrumed, Inc. devices

Submission Details

510(k) Number K860617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1986
Decision Date March 03, 1986
Days to Decision 12 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 102d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTC Device, Microtiter Diluting/dispensing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2500
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 - JTC Device, Microtiter Diluting/dispensing

All 7
Devices cleared under the same product code (JTC) and FDA review panel - the closest regulatory comparables to K860617.
WASHER 500 MICROELISA SYSTEM
K884695 · Organon Teknika Corp. · Dec 1988
WASHER 6000 MICRO-C LISA SYSTEM
K831640 · Organon Teknika Corp. · Aug 1983
PIPETTE 12 CHANNEL
K831644 · Organon Teknika Corp. · Aug 1983
MUELLER HINTON W/50% SHEEP BLOOD
K830059 · bioMerieux, Inc. · Feb 1983
SCEPTOR SYSTEM AUTOMATED MODEL 216
K810229 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1981
HIPPURATE DISK
K801305 · Remel Co. · Jul 1980