510(k) · Cleared
ClearedBÜHLMANN fCAL® turbo and CALEX® Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bühlmann Laboratories AG · NXO Calprotectin, Fecal
Cleared on Feb 6, 2024 as substantially equivalent to K191718 (Buhlmann Laboratories AG, 2019) after a 210-day review. Its family tree reaches back 6 generations to 2006.
- Decided
- Feb 6, 2024
- Review
- 210 days
- Class
- Class II
- Product code
- NXO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN060001 (2006). No later device cites it as a predicate yet.
- Root · 6 generations backDEN060001 Phical TestGenova Diagnostics · 2006
- 5 generations backK130945 CalprestEurospital S.P.A. · 2014
- 4 generations backK160447 Calprest NGEurospital S.P.A. · 2016
- 3 generations backK181012 BUHLMANN fCAL ELISABuhlmann Laboratories AG · 2018
- 2 generations backK190784 BUHLMANN fCAL turboBuhlmann Laboratories AG · 2019
- 1 generation backK191718 Buhlmann fCAL turbo and CALEX CapBuhlmann Laboratories AG · 2019
- This deviceK232057 BÜHLMANN fCAL® turbo and CALEX® CapBühlmann Laboratories AG · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN060001 | Phical Test | Genova Diagnostics | 2006 | — |
| −5 | K130945 | Calprest | Eurospital S.P.A. | 2014 | — |
| −4 | K160447 | Calprest NG | Eurospital S.P.A. | 2016 | — |
| −3 | K181012 | BUHLMANN fCAL ELISA | Buhlmann Laboratories AG | 2018 | — |
| −2 | K190784 | BUHLMANN fCAL turbo | Buhlmann Laboratories AG | 2019 | — |
| −1 | K191718 | Buhlmann fCAL turbo and CALEX Cap | Buhlmann Laboratories AG | 2019 | — |
| 0 (this device) | K232057 | BÜHLMANN fCAL® turbo and CALEX® Cap | Bühlmann Laboratories AG | 2024 | — |
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 NXO? 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 NXO device
- #1 K213858 LIAISON Calprotectin, LIAISON Q.S.E.T. Device…score 2.9 · 5 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 |
|---|---|---|---|
| * | K191718 | Buhlmann fCAL turbo and CALEX CapSummary page 4…NXO Device Classification II III. Predicate Device Substantial equivalence is claimed to the following device: • BÜHLMANN fCAL® turbo, K191718, BÜHLMANN Laboratories AG IV. Device Description The BÜHLMANN fCAL® turbo, a particle-enhanced turbidimetric immunoassay… | 2019 |
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 18 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All NXO devicesNXO Calprotectin, Fecal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · NXO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NXO
90in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NXO
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NXO
1in 2022
MAUDE reports naming product code NXO, not matched to any one device; reports are not rates.
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 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 90 | 0 | 0 |
| 2019 | 5 | 90 | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 1 | 0 |
| 2025 | 0 | — | 2 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BÜHLMANN fCAL® turbo is an in vitro diagnostic assay intended for the quantitative measurement of fecal calprotectin, a neutrophilic protein that is a marker of intestinal mucosal inflammation, in human stool. The BÜHLMANN fCAL® turbo aids in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC) and aids in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other laboratory and clinical findings.
The BÜHLMANN CALEX® Cap is a single use tube intended for the preparation of human stool samples to be used with the BÜHLMANN fCAL® turbo.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232057: BÜHLMANN fCAL® turbo and CALEX® Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232057
Report an extraction error
Are you the manufacturer?
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