510(k) Report

510(k) · Cleared

Cleared

PhenoMATRIX

K251511510(k) TraditionalCleared Jan 22, 2026251-day reviewClass II21 CFR 866.2190

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Copan Wasp Srl · PPU Microbial Colony Image Assessment System

Cleared on Jan 22, 2026 as substantially equivalent to K183648 (Clever Culture Systems AG, 2019) and 1 other predicate after a 251-day review. Its family tree reaches back 3 generations to 2016.

Decided
Jan 22, 2026
Review
251 days
Class
Class II
Product code
PPU
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to DEN150059 (2016). No later device cites it as a predicate yet.

DEN150059 · APAS Compact with Urine Analysis Module · Clever Culture Systems AG · 2016K183648 · APAS Independence with Urine Analysis Module · Clever Culture Systems AG · 2019K200839 · APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module · Clever Culture Systems · 20212016201820202022202420262028
K200839 · APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module · Clever Culture Systems · 2021K183648 · APAS Independence with Urine Analysis Module · Clever Culture Systems AG · 2019DEN150059 · APAS Compact with Urine Analysis Module · Clever Culture Systems AG · 20160
  1. Root · 3 generations backDEN150059 APAS Compact with Urine Analysis ModuleClever Culture Systems AG · 2016
  2. 2 generations backK183648 APAS Independence with Urine Analysis ModuleClever Culture Systems AG · 2019
  3. 1 generation backK200839 APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS…Clever Culture Systems · 2021
  4. This deviceK251511 PhenoMATRIXCopan Wasp Srl · 2026
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3DEN150059APAS Compact with Urine Analysis ModuleClever Culture Systems AG2016—
−2K183648APAS Independence with Urine Analysis ModuleClever Culture Systems AG2019—
−1K200839APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS…Clever Culture Systems2021—
0 (this device)K251511PhenoMATRIXCopan Wasp Srl2026—
FIG. 1 — Lineage of K251511, 2016–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K183648APAS Independence with Urine Analysis Module
Our reading of the summary gave K183640, FDA’s number for Cellvizio 100 Series Confocal laser Imaging systems and… (Mauna Kea Technologies). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “APAS Indipendence with Urine Analysis Module”.
Clever Culture Systems AG2019—
*K200839APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC…
Summary page 6
…Module; APAS Independence with IC Chromogenic MRSA TFS/S Analysis Module 510(K) Number K200839 4. DEVICE DESCRIPTION The PhenoMATRIX is an in vitro diagnostic software for automated classification of images of solid cu…
Clever Culture Systems2021—

Also cleared against K183648: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
  • None of the 3 ancestors has a recall.
  • 1 other device also cites its predicate K183648.

How does its category compare?

All PPU devices

PPU Microbial Colony Image Assessment System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.

FDA decisions per year · PPU

1in 2019

2016: 12019: 12026 (partial year): 1
2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PPU

Too few PPU 510(k)s in any year since 2007 to give a median.

Recalls per year · PPU

No recall names PPU since 2007.

Adverse event reports per year · PPU

No MAUDE report names PPU since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20161—00
20170—00
20180—00
20191—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20261—0—

What is it indicated for?

PhenoMATRIX is a WASPLab optional module intended for the automatic sorting of images of blood-based agar, chocolate agar, MacConkey agar, and CHROMagar Orientation culture media plates according to classification parameters based on Image Analysis Software results and clinical and demographic data. Image Analysis Software performs semi-quantitative and/or qualitative analysis of culture media plates by detecting microbial growth, estimating colony…

Read the full statement (109 words)

PhenoMATRIX is a WASPLab optional module intended for the automatic sorting of images of blood-based agar,

chocolate agar, MacConkey agar, and CHROMagar Orientation culture media plates according to classification

parameters based on Image Analysis Software results and clinical and demographic data.

Image Analysis Software performs semi-quantitative and/or qualitative analysis of culture media plates by detecting

microbial growth, estimating colony counts and differentiating isolates based on phenotypic colony characteristics.

The system determines how the images should be sorted based on image analysis results in addition to patient data

according to expert rules defined by the laboratory.

All images shall be evaluated by trained personnel for final assessment and result definition.

Indications for use as stated in the FDA summary.

Also cleared against K183648

1 other device cites the same predicate.

  • K200839APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC Chromogenic MRSA…Clever Culture Systems · 2021

More from Copan Wasp Srl

5 FDA decisions under this applicant name. See the company

  • K232756ColibríCopan Wasp Srl · 2023
  • K223245ColibríCopan Wasp Srl · 2023
  • K220546Colibrí SystemCopan Wasp Srl · 2022
  • K193138Colibri SystemCopan Wasp Srl · 2021

Recent decisions in PPU

The PPU category page

  • K183648APAS Independence with Urine Analysis ModuleClever Culture Systems AG · 2019
  • DEN150059APAS Compact with Urine Analysis ModuleClever Culture Systems AG · 2016

https://510kreport.com/device/K251511 · printed Nov 6, 2026

Cite this page

510(k) Report. “K251511: PhenoMATRIX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251511

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026