510(k) · Cleared
ClearedBUHLMANN fCAL ELISA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Buhlmann Laboratories AG · NXO Calprotectin, Fecal
Cleared on Jun 4, 2018 as substantially equivalent to K160447 (Eurospital S.P.A., 2016) after a 48-day review. Its family tree reaches back 3 generations to 2006. 3 later devices descend from it.
- Decided
- Jun 4, 2018
- Review
- 48 days
- Class
- Class II
- Product code
- NXO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN060001 (2006). 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backDEN060001 Phical TestGenova Diagnostics · 2006
- 2 generations backK130945 CalprestEurospital S.P.A. · 2014
- 1 generation backK160447 Calprest NGEurospital S.P.A. · 2016
- This deviceK181012 BUHLMANN fCAL ELISABuhlmann Laboratories AG · 2018
- Descendant · cites it directly · 2 of its ownK190784 BUHLMANN fCAL turboBuhlmann Laboratories AG · 2019
- Descendant · 2 generations on · 1 of its ownK191718 Buhlmann fCAL turbo and CALEX CapBuhlmann Laboratories AG · 2019
- Descendant · 3 generations on · 0 of its ownK232057 BÜHLMANN fCAL® turbo and CALEX® CapBühlmann Laboratories AG · 2024
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN060001 | Phical Test | Genova Diagnostics | 2006 | — |
| −2 | K130945 | Calprest | Eurospital S.P.A. | 2014 | — |
| −1 | K160447 | Calprest NG | Eurospital S.P.A. | 2016 | — |
| 0 (this device) | K181012 | BUHLMANN fCAL ELISA | Buhlmann Laboratories AG | 2018 | — |
| +1 | K190784 | BUHLMANN fCAL turbo | Buhlmann Laboratories AG | 2019 | — |
| +2 | K191718 | Buhlmann fCAL turbo and CALEX Cap | Buhlmann Laboratories AG | 2019 | — |
| +3 | K232057 | BÜHLMANN fCAL® turbo and CALEX® Cap | Bühlmann Laboratories AG | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2024 | 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 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 K232057 BÜHLMANN fCAL® turbo and CALEX® Capscore 8.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
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 |
|---|---|---|---|
| * | K160447 | Calprest NGSummary page 4…NXO Device Classification II III. Predicate Device Substantial equivalence is claimed to the following device: • Calprest®NG, K160447, Eurospital S.p.A. IV. Device Description The BÜHLMANN fCAL® ELISA is an enzyme-linked immunosorbent assay (ELISA) perfo… | 2016 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190784 | BUHLMANN fCAL turbo | 2019 | 2 |
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 12 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K190784 (Buhlmann Laboratories AG, 2019) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K160447.
How does its category compare?
All NXO devicesNXO Calprotectin, Fecal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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® ELISA is an in vitro diagnostic assay intended for the quantitative measurement of fecal calprotectin in human stool. The BÜHLMANN fCAL® ELISA 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181012: BUHLMANN fCAL ELISA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181012
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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