Cleared Traditional

K842057 - MACLEAN-FOGG, DISPOS-INOCULA-LOOPS

K842057 is an FDA 510(k) clearance for MACLEAN-FOGG, manufactured by Polymer Technology Corp.. The device is a Class 1 Microbiology device with product code LIB cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K842057 · Polymer Technology Corp. · Microbiology device

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Jun 1984

Decision

16d

Days

Class 1

Risk

K842057 is an FDA 510(k) clearance for the MACLEAN-FOGG, DISPOS-INOCULA-LOOPS. Classified as Device, General Purpose, Microbiology, Diagnostic (product code LIB), Class I - General Controls.

Submitted by Polymer Technology Corp. (Mchenry, US). The FDA issued a Cleared decision on June 7, 1984 after a review of 16 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.

FDA 510(k) Submission Details - K842057

510(k) Number	K842057 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 22, 1984
Decision Date	June 07, 1984
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

86d faster than avg

Panel avg: 102d · This submission: 16d

Pathway characteristics

Predicate-based equivalence.

LIB Device Classification - Class 1, General Controls

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 42

Devices cleared under the same product code (LIB) and FDA review panel - the closest regulatory comparables to K842057.

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FDA 510(k) Resources - Microbiology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K842057

Polymer Technology Corp.

Mchenry, IL · US

Regulatory profile

23 submissions 23 cleared

100% clearance rate · Active in Microbiology

View all devices by Polymer Technology Corp. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: June 7, 1984. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: August 2026.

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