Cleared Traditional

K981391 - PAR-ONE

K981391 is an FDA 510(k) clearance for PAR-ONE, manufactured by Remel, Inc.. The device is a Class 1 Microbiology device with product code LIO cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K981391 · Remel, Inc. · Microbiology device
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Jul 1998
Decision
88d
Days
Class 1
Risk

K981391 is an FDA 510(k) clearance for the PAR-ONE. Classified as Device, Specimen Collection (product code LIO), Class I - General Controls.

Submitted by Remel, Inc. (Lenexa, US). The FDA issued a Cleared decision on July 14, 1998 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - 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 Remel, Inc. devices

FDA 510(k) Submission Details - K981391

510(k) Number K981391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1998
Decision Date July 14, 1998
Days to Decision 88 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 102d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

LIO Device Classification - Class 1, General Controls

Product Code LIO Device, Specimen Collection
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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.

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All 23
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