510(k) · Cleared
ClearedTriage B-Type Natriuretic Peptide (BNP) Test, Catalog #98000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosite Incorporated · NBC Test, Natriuretic Peptide
Cleared on Mar 16, 2001 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Mar 16, 2001
- Review
- 46 days
- Class
- Class II
- Product code
- NBC
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK010266 Triage B-Type Natriuretic Peptide (BNP) Test, Catalog #98000Biosite Incorporated · 2001
- Descendant · cites it directly · 4 of its ownK031038 Advia Centaur B-Type Natriuretic Peptide (BNP) AssayBayer Healthcare, LLC · 2003 · Recalled
- Descendant · cites it directly · 2 of its ownK093758 BGM Galectin -3Bg Medicine, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK192380 ST Aia-Pack BNPFujirebio Diagnostics,Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK040425 Acs:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) AssaysBayer Healthcare, LLC · 2004
- Descendant · 3 generations on · 0 of its ownK211199 ST AIA-PACK BNP AssayTosoh Bioscience, Inc. · 2021
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K031038Advia Centaur B-Type Natriuretic Peptide (BNP) AssayBayer Healthcare, LLC · 2003 · cites it directly4descendants
- K093758BGM Galectin -3Bg Medicine, Inc. · 2010 · cites it directly2descendants
- K192380ST Aia-Pack BNPFujirebio Diagnostics,Inc. · 2020 · 2 generations on1descendant
- K040425Acs:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) AssaysBayer Healthcare, LLC · 2004 · 2 generations on1descendant
- K211199ST AIA-PACK BNP AssayTosoh Bioscience, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010266 | Triage B-Type Natriuretic Peptide (BNP) Test, Catalog #98000 | Biosite Incorporated | 2001 | — |
| +1 | K031038 | Advia Centaur B-Type Natriuretic Peptide (BNP) Assay | Bayer Healthcare, LLC | 2003 | 6 |
| +1 | K093758 | BGM Galectin -3 | Bg Medicine, Inc. | 2010 | — |
| +2 | K192380 | ST Aia-Pack BNP | Fujirebio Diagnostics,Inc. | 2020 | — |
| +2 | K040425 | Acs:180 and Advia Centaur B-Type Natriuretic Peptide (BNP) Assays | Bayer Healthcare, LLC | 2004 | — |
| +3 | K211199 | ST AIA-PACK BNP Assay | Tosoh Bioscience, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NBC? 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 NBC device
- #1 K262109 Access NT-proBNPscore 13.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
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?
- Of its descendants, K031038 (Bayer Healthcare, LLC, 2003) has gone furthest, with 4 descendants of its own.
How does its category compare?
All NBC devicesNBC Test, Natriuretic Peptide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NBC
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBC
126in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBC
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NBC
17in 2025
MAUDE reports naming product code NBC, 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 | 2 | — | 0 | 17 |
| 2008 | 7 | 126 | 0 | 15 |
| 2009 | 0 | — | 0 | 35 |
| 2010 | 1 | — | 1 | 61 |
| 2011 | 0 | — | 0 | 53 |
| 2012 | 0 | — | 2 | 23 |
| 2013 | 0 | — | 0 | 13 |
| 2014 | 0 | — | 1 | 70 |
| 2015 | 0 | — | 1 | 43 |
| 2016 | 0 | — | 0 | 31 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 1 | 7 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 1 | — | 1 | 6 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 26 |
| 2024 | 1 | — | 0 | 14 |
| 2025 | 1 | — | 0 | 17 |
| 2026 | 4 | 94 | 0 | — |
https://510kreport.com/device/K010266 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010266: Triage B-Type Natriuretic Peptide (BNP) Test, Catalog #98000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010266
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026