Cleared Traditional

K232756 - Colibrí

K232756 is an FDA 510(k) clearance for Colibrí, manufactured by Copan Wasp Srl. The device is a Class 2 Microbiology device with product code LON cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K232756 · Copan Wasp Srl · Microbiology device
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Dec 2023
Decision
110d
Days
Class 2
Risk

K232756 is an FDA 510(k) clearance for the Colibrí. Classified as System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (product code LON), Class II - Special Controls.

Submitted by Copan Wasp Srl (Brescia, IT). The FDA issued a Cleared decision on December 27, 2023 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1645 - 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 Copan Wasp Srl devices

FDA 510(k) Submission Details - K232756

510(k) Number K232756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2023
Decision Date December 27, 2023
Days to Decision 110 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 102d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LON Device Classification - Class 2, Special Controls

Product Code LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1645
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.

Regulatory Peers - LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

All 281
Devices cleared under the same product code (LON) and FDA review panel - the closest regulatory comparables to K232756.
BD Phoenix™ Automated Microbiology System
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K232201 · bioMerieux, Inc. · Oct 2023
VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin
K230864 · bioMerieux, Inc. · Jul 2023
VITEK 2 AST-Gram Negative Levofloxacin (/=8 ug/mL)
K222378 · bioMerieux, Inc. · Jun 2023