510(k) · Cleared
ClearedAPAS Independence with Urine Analysis Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clever Culture Systems AG · PPU Microbial Colony Image Assessment System
Cleared on May 15, 2019 as substantially equivalent to DEN150059 (Clever Culture Systems AG, 2016) after a 140-day review. Its family tree reaches back 1 generation to 2016. 3 later devices descend from it.
- Decided
- May 15, 2019
- Review
- 140 days
- Class
- Class II
- Product code
- PPU
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN150059 (2016). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backDEN150059 APAS Compact with Urine Analysis ModuleClever Culture Systems AG · 2016
- This deviceK183648 APAS Independence with Urine Analysis ModuleClever Culture Systems AG · 2019
- Descendant · cites it directly · 2 of its ownK200839 APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS…Clever Culture Systems · 2021
- Descendant · cites it directly · 0 of its ownK251511 PhenoMATRIXCopan Wasp Srl · 2026
- Descendant · 2 generations on · 0 of its ownK213280 BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA)…Bd Kiestra B.V. · 2023
Most influential descendants
Showing 3 of 3 · See all- K200839APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS Independence with IC…Clever Culture Systems · 2021 · cites it directly2descendants
- K251511PhenoMATRIXCopan Wasp Srl · 2026 · cites it directly0descendants
- K213280BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra…Bd Kiestra B.V. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN150059 | APAS Compact with Urine Analysis Module | Clever Culture Systems AG | 2016 | — |
| 0 (this device) | K183648 | APAS Independence with Urine Analysis Module | Clever Culture Systems AG | 2019 | — |
| +1 | K200839 | APAS Independence with IC Chromogenic MRSA BD Analysis Module; APAS… | Clever Culture Systems | 2021 | — |
| +1 | K251511 | PhenoMATRIX | Copan Wasp Srl | 2026 | — |
| +2 | K213280 | BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD… | Bd Kiestra B.V. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
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.
Planning a device in PPU? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PPU device
- #1 K251511 PhenoMATRIXscore 11.3 · 3 generations · no Class I recall
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN150059 | APAS Compact with Urine Analysis ModuleSummary page 3…ies on solid culture media (21 CFR 866.2190). Regulatory Class: II (special controls). Product Code: PPU. 5.3 Predicate Device APAS Compact with Urine Analysis Module, DEN150059. This predicate has not been subject to a design related recall. No reference devices were used in this submission. 5.4 Device… | 2016 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has no recall.
- Of its descendants, K200839 (Clever Culture Systems, 2021) has gone furthest, with 2 descendants of its own.
How does its category compare?
All PPU devicesPPU Microbial Colony Image Assessment System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · PPU
1in 2019
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
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The APAS Independence is an in vitro diagnostic system comprised of an instrument for automated imaging of agar culture plates and a software analysis module for the following use: The APAS Independence, when using its urine analysis module, automates urine culture plate imaging and interpretation to detect the presence or absence of microbial growth on sheep blood and MacConkey agar culture plates that are inoculated with a 1μL sample volume. The APAS…
Read the full statement (127 words)
The APAS Independence is an in vitro diagnostic system comprised of an instrument for automated imaging of agar culture plates and a software analysis module for the following use:
The APAS Independence, when using its urine analysis module, automates urine culture plate imaging and interpretation to detect the presence or absence of microbial growth on sheep blood and MacConkey agar culture plates that are inoculated with a 1μL sample volume. The APAS Independence, when using its urine analysis module, 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 that are identified as positive for growth by the APAS Independence, when using its urine analysis module, must be reviewed by a trained microbiologist.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183648 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183648: APAS Independence with Urine Analysis Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183648
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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