510(k) · Cleared
ClearedAccess BNP II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · NBC Test, Natriuretic Peptide
Cleared on Mar 24, 2026 as substantially equivalent to K052789 (Biosite Incorporated, 2006) after a 257-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Mar 24, 2026
- Review
- 257 days
- Class
- Class II
- Product code
- NBC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN000010 (2000). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backDEN000010 Triage B-Type Natriuretic Peptide (BNP) TestBiosite Incorporated · 2000
- 4 generations backK022516 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2002
- 3 generations backK032646 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2003
- 2 generations backK051787 Triage BNP Test, Model 98000XRBiosite Incorporated · 2005
- 1 generation backK052789 Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200Biosite Incorporated · 2006 · Recalled
- This deviceK252169 Access BNP IIBeckman Coulter, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN000010 | Triage B-Type Natriuretic Peptide (BNP) Test | Biosite Incorporated | 2000 | — |
| −4 | K022516 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2002 | — |
| −3 | K032646 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2003 | — |
| −2 | K051787 | Triage BNP Test, Model 98000XR | Biosite Incorporated | 2005 | — |
| −1 | K052789 | Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200 | Biosite Incorporated | 2006 | 1 |
| 0 (this device) | K252169 | Access BNP II | Beckman Coulter, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 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 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? (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 |
|---|---|---|---|
| * | K052789 | Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200Summary page 5…s BNP II Classification Name: B-Type Natriuretic Peptide Test System Classification Regulation: [21 CFR 862.1117] Predicate Device Device Name: BNP Test 510(k) Numbers: K052789 Device Description The Access BNP II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative dete… | 2006 |
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 26 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K052789.
How does its category compare?
All NBC devicesNBC Test, Natriuretic Peptide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The Access BNP II test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications:
∙ as an aid in the diagnosis of heart failure (HF) in patients presenting to the emergency department (ED) with clinical suspicion of new onset, acutely decompensated, or exacerbated heart failure
∙ for the risk stratification of patients with acute coronary syndromes
∙ for the risk stratification of patients with heart failure
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252169: Access BNP II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252169
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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