Cleared Traditional

K221493 - MicroScan Prompt Inoculation System-D

K221493 is an FDA 510(k) clearance for MicroScan Prompt Inoculation System-D, manufactured by Beckman Coulter, Inc.. The device is a Class 2 Microbiology device with product code LIE cleared through the Traditional 510(k) pathway after a 317-day FDA review.

K221493 · Beckman Coulter, Inc. · Microbiology device
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Apr 2023
Decision
317d
Days
Class 2
Risk

K221493 is an FDA 510(k) clearance for the MicroScan Prompt Inoculation System-D. Classified as Reagent/device, Inoculum Calibration (product code LIE), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (West Sacramento, US). The FDA issued a Cleared decision on April 5, 2023 after a review of 317 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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. Elevated predicate reliance profile. 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 Beckman Coulter, Inc. devices

FDA 510(k) Submission Details - K221493

510(k) Number K221493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2022
Decision Date April 05, 2023
Days to Decision 317 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
215d slower than avg
Panel avg: 102d · This submission: 317d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIE Device Classification - Class 2, Special Controls

Product Code LIE Reagent/device, Inoculum Calibration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.