PhenoMATRIX

FDA 510(k) K251511 · Copan Wasp Srl

Substantially Equivalent

510(k) numberK251511

Submission

Device name
PhenoMATRIX
Applicant
Copan Wasp Srl
Brescia, IT
Received
May 16, 2025
Decision date
January 22, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PPU – Microbial Colony Image Assessment System
Device class
Class II (moderate risk)
Regulation
21 CFR 866.2190
Specialty
Microbiology

A microbial colony image assessment system is an instrument that is intended to assess the presence or absence of microbial colonies on solid microbiological culture medium, and to interpret their number, phenotypic and morphologic characteristics. This device type provides a semi-quantitative assessment of colony counts that are used as an aid in the diagnosis of urinary tract infection. All…

Other 510(k)s with product code PPU

510(k)DeviceApplicantDecision
K183648APAS Independence with Urine Analysis ModulePPU · Traditional Clever Culture Systems AG05/15/2019SE

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Questions and answers

When was PhenoMATRIX cleared by the FDA?

PhenoMATRIX (K251511) received a 510(k) decision of Substantially Equivalent on January 22, 2026, 251 days after the submission was received.

What is the product code of K251511?

The FDA product code is PPU – Microbial Colony Image Assessment System, a Class II (moderate risk) device regulated under 21 CFR 866.2190.