510(k) Report

FDA product code · Microbiology

Microbial Colony Image Assessment System

PPUClass II21 CFR 866.2190510(k) required3 decisions since 20160 recalls

3 FDA decisions since 2016. No recall names this code. The most-cited predicate is K183648, named by 2 later devices.

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 urine culture plates…

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

FIG. A — Illustration, microbiology panel

Twenty years of PPU at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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—
FIG. 1 — PPU by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in PPU? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do PPU devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K183648APAS Independence with Urine Analysis ModuleClever Culture Systems AG · 20192cite it
  • DEN150059APAS Compact with Urine Analysis ModuleClever Culture Systems AG · 20161cites it

Which PPU devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K251511PhenoMATRIXCopan Wasp Srl · 20263generations
  • K183648APAS Independence with Urine Analysis ModuleClever Culture Systems AG · 20191generation

What has FDA decided in PPU lately?

  • K251511PhenoMATRIXCopan Wasp Srl · 2026
  • K183648APAS Independence with Urine Analysis ModuleClever Culture Systems AG · 2019
  • DEN150059APAS Compact with Urine Analysis ModuleClever Culture Systems AG · 2016

All 3 PPU decisions →

Related product codes

Other codes under 21 CFR 866.2190.

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