510(k) · Cleared
ClearedCalprest NG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eurospital S.P.A. · NXO Calprotectin, Fecal
Cleared on Nov 10, 2016 as substantially equivalent to K130945 (Eurospital S.P.A., 2014) after a 267-day review. Its family tree reaches back 2 generations to 2006. 8 later devices descend from it.
- Decided
- Nov 10, 2016
- Review
- 267 days
- Class
- Class II
- Product code
- NXO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN060001 (2006). 8 later devices descend from it, 4 citing it directly.
- Root · 2 generations backDEN060001 Phical TestGenova Diagnostics · 2006
- 1 generation backK130945 CalprestEurospital S.P.A. · 2014
- This deviceK160447 Calprest NGEurospital S.P.A. · 2016
- Descendant · cites it directly · 3 of its ownK181012 BUHLMANN fCAL ELISABuhlmann Laboratories AG · 2018
- Descendant · 2 generations on · 2 of its ownK190784 BUHLMANN fCAL turboBuhlmann Laboratories AG · 2019
- Descendant · 3 generations on · 1 of its ownK191718 Buhlmann fCAL turbo and CALEX CapBuhlmann Laboratories AG · 2019
- Descendant · cites it directly · 1 of its ownK170993 QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin…Inova Diagnostics, Inc. · 2017
- Descendant · 4 generations on · 0 of its ownK232057 BÜHLMANN fCAL® turbo and CALEX® CapBühlmann Laboratories AG · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K181012BUHLMANN fCAL ELISABuhlmann Laboratories AG · 2018 · cites it directly3descendants
- K190784BUHLMANN fCAL turboBuhlmann Laboratories AG · 2019 · 2 generations on2descendants
- K191718Buhlmann fCAL turbo and CALEX CapBuhlmann Laboratories AG · 2019 · 3 generations on1descendant
- K170993QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash…Inova Diagnostics, Inc. · 2017 · cites it directly1descendant
- K232057BÜHLMANN fCAL® turbo and CALEX® CapBühlmann Laboratories AG · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN060001 | Phical Test | Genova Diagnostics | 2006 | — |
| −1 | K130945 | Calprest | Eurospital S.P.A. | 2014 | — |
| 0 (this device) | K160447 | Calprest NG | Eurospital S.P.A. | 2016 | — |
| +1 | K181012 | BUHLMANN fCAL ELISA | Buhlmann Laboratories AG | 2018 | — |
| +2 | K190784 | BUHLMANN fCAL turbo | Buhlmann Laboratories AG | 2019 | — |
| +3 | K191718 | Buhlmann fCAL turbo and CALEX Cap | Buhlmann Laboratories AG | 2019 | — |
| +1 | K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators… | Inova Diagnostics, Inc. | 2017 | — |
| +4 | K232057 | BÜHLMANN fCAL® turbo and CALEX® Cap | Bühlmann Laboratories AG | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 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 |
|---|---|---|---|
| * | K130945 | CalprestSummary page 4…ich the submitter claims substantial equivalence: Predicate Device Name: Calprest® 510(k) Number: K130945 Regulation Number: 21CFR866.5180 Regulati… | 2014 |
What descends from it? (8)
4 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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 7.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K181012 (Buhlmann Laboratories AG, 2018) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K130945.
How does its category compare?
All NXO devicesNXO Calprotectin, Fecal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Calprest®NG is a quantitative ELISA for detecting concentration of fecal calprotectin, which can be used as an in vitro diagnostic to aid in the diagnosis of Inflammatory Bowel Diseases (IBD), specifically Crohn’s disease and ulcerative colitis, and to differentiate IBD from Irritable Bowel Syndrome (IBS) in conjunction with other clinical and laboratory findings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160447 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160447: Calprest NG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160447
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