510(k) · Cleared
ClearedAccess NT-proBNP
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 Apr 12, 2024 as substantially equivalent to K072437 (Roche Diagnostics, 2008) after a 266-day review. Its family tree reaches back 6 generations to 1993. 1 later device descends from it.
- Decided
- Apr 12, 2024
- Review
- 266 days
- Class
- Class II
- Product code
- NBC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K931172 (1993). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK931172 Imx (R) Stat CK-MBAbbott Laboratories · 1993
- 5 generations backK961501 Elecsys CK-MBBoehringer Mannheim Corp. · 1996
- 4 generations backK962575 Elecsys Precicontrol CardiacBoehringer Mannheim Corp. · 1996
- 3 generations backK983492 Boehringer Mannheim Elecsys Presicontrol CardiacBoehringer Mannheim Corp. · 1998
- 2 generations backK032089 Roche Diagnostics Elecsys Precicontrol CardiacRoche Diagnostics Corp. · 2003
- 1 generation backK072437 Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetRoche Diagnostics · 2008
- This deviceK232164 Access NT-proBNPBeckman Coulter, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK262109 Access NT-proBNPBeckman Coulter, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K262109Access NT-proBNPBeckman Coulter, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K931172 | Imx (R) Stat CK-MB | Abbott Laboratories | 1993 | — |
| −5 | K961501 | Elecsys CK-MB | Boehringer Mannheim Corp. | 1996 | — |
| −4 | K962575 | Elecsys Precicontrol Cardiac | Boehringer Mannheim Corp. | 1996 | — |
| −3 | K983492 | Boehringer Mannheim Elecsys Presicontrol Cardiac | Boehringer Mannheim Corp. | 1998 | — |
| −2 | K032089 | Roche Diagnostics Elecsys Precicontrol Cardiac | Roche Diagnostics Corp. | 2003 | — |
| −1 | K072437 | Elecsys Probnp II, Precicontrol Cardiac II, Probnp II Calset | Roche Diagnostics | 2008 | — |
| 0 (this device) | K232164 | Access NT-proBNP | Beckman Coulter, Inc. | 2024 | — |
| +1 | K262109 | Access NT-proBNP | Beckman Coulter, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K072437 | Elecsys Probnp II, Precicontrol Cardiac II, Probnp II CalsetSummary page 4…cation name: B-Type natriuretic peptide test system Classification Regulation: 21 CFR 862.1117 Classification Product Code: NBC Predicate Device: Elecsys® proBNP II - k072437 Reference Device: VITROS® NT-proBNP II – k201312 Device Description The Access NT-proBNP assay is a paramagnetic particle, che… | 2008 |
| † | K201312 | VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K262109 | Access NT-proBNP | 2026 | 0 |
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 31 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K262109 (Beckman Coulter, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K072437.
How does its category compare?
All NBC devicesNBC Test, Natriuretic Peptide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 NT-proBNP assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of N-terminal pro B-type natriuretic peptide levels in human serum and plasma using the automated DxI Access Immunoassay Analyzers to aid in the following:
1. diagnosis of patients suspected of having acute heart failure in the Emergency Department
2. assessment of heart failure severity
3. risk stratification of patients with heart failure
4. risk stratification of patients with acute coronary syndrome
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232164 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232164: Access NT-proBNP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232164
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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