510(k) · Cleared
Recalled · Class II · 2021Behring Coagulation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Behring Diagnostics, Inc. · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on May 5, 1997 as substantially equivalent to K955278 (Behring Diagnostics, Inc., 1996) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- May 5, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- JPA
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K926551 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK926551 Behring Fibrintimer aBehring Diagnostics, Inc. · 1995
- 1 generation backK955278 Behring Coagulation TimerBehring Diagnostics, Inc. · 1996
- This deviceK970431 Behring Coagulation SystemBehring Diagnostics, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK020979 Sysmex Automated Coagulation Analyzer, Model #CA-7000Dade Behring, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK031377 Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520…Dade Behring, Inc. · 2003
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K926551 | Behring Fibrintimer a | Behring Diagnostics, Inc. | 1995 | — |
| −1 | K955278 | Behring Coagulation Timer | Behring Diagnostics, Inc. | 1996 | — |
| 0 (this device) | K970431 | Behring Coagulation System | Behring Diagnostics, Inc. | 1997 | — |
| +1 | K020979 | Sysmex Automated Coagulation Analyzer, Model #CA-7000 | Dade Behring, Inc. | 2002 | — |
| +2 | K031377 | Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520, -530, -540.… | Dade Behring, Inc. | 2003 | — |
Descendants 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 JPA? 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 JPA device
- #1 K243858 TEG 6s Hemostasis System Citrated: K, KH, RT…score 12.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K955278 | Behring Coagulation TimerSummary page 1…f specific parameters in plasma. . Substantial Equivalence: Behring Diagnostics Inc. considers the BCS to be substantially equivalent to the Behring Coagulation Timer (K955278) and the Behring Fibrintimer A (K926551) in terms of intended use, instrument features, and overall performance characteristics.… | 1996 |
| * | K926551 | Behring Fibrintimer aSummary page 1…tantial Equivalence: Behring Diagnostics Inc. considers the BCS to be substantially equivalent to the Behring Coagulation Timer (K955278) and the Behring Fibrintimer A (K926551) in terms of intended use, instrument features, and overall performance characteristics. . Device Description and Performance Ch… | 1995 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020979 | Sysmex Automated Coagulation Analyzer, Model #CA-7000 | 2002 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 2, 2021 | Class II | Z-1435-2021 | Under Investigation by firm | Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples. |
| Jan 14, 2016 | Class II | Z-0825-2016 | Software design | False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K020979 (Dade Behring, Inc., 2002) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K955278.
How does its category compare?
All JPA devicesJPA System, Multipurpose For In Vitro Coagulation Studies: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JPA
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JPA
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JPA
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPA
11in 2025
MAUDE reports naming product code JPA, 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 | 1 | — | 1 | 1,744 |
| 2008 | 2 | — | 0 | 918 |
| 2009 | 6 | 91 | 0 | 1,363 |
| 2010 | 1 | — | 6 | 727 |
| 2011 | 1 | — | 4 | 161 |
| 2012 | 0 | — | 1 | 52 |
| 2013 | 1 | — | 0 | 43 |
| 2014 | 0 | — | 0 | 48 |
| 2015 | 2 | — | 0 | 45 |
| 2016 | 6 | 114 | 3 | 6 |
| 2017 | 4 | 117 | 0 | 15 |
| 2018 | 1 | — | 0 | 39 |
| 2019 | 3 | 175 | 0 | 27 |
| 2020 | 0 | — | 1 | 18 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 1 | — | 0 | 9 |
| 2023 | 3 | 506 | 0 | 11 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 3 | 30 | 0 | 11 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Behring Coagulation System is an instrument intended to perform quantitative assays of specific parameters in plasma.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970431: Behring Coagulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970431
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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