510(k) · Cleared
ClearedBehring Fibrintimer a
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 Apr 18, 1995 after an 838-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Apr 18, 1995
- Review
- 838 days
- Class
- Class II
- Product code
- JPA
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK926551 Behring Fibrintimer aBehring Diagnostics, Inc. · 1995
- Descendant · cites it directly · 10 of its ownK955278 Behring Coagulation TimerBehring Diagnostics, Inc. · 1996
- Descendant · 2 generations on · 4 of its ownK992321 Sysmex Automated Coagulation Analyzer, Model CA-6000Dade Behring, Inc. · 1999
- Descendant · 2 generations on · 2 of its ownK993174 Sysmex Automated Coagulation Analyzer, Model CA-6000Dade Behring, Inc. · 1999
- Descendant · cites it directly · 2 of its ownK970431 Behring Coagulation SystemBehring Diagnostics, Inc. · 1997 · Recalled
- Descendant · 2 generations on · 1 of its ownK020979 Sysmex Automated Coagulation Analyzer, Model #CA-7000Dade Behring, Inc. · 2002
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K955278Behring Coagulation TimerBehring Diagnostics, Inc. · 1996 · cites it directly10descendants
- K992321Sysmex Automated Coagulation Analyzer, Model CA-6000Dade Behring, Inc. · 1999 · 2 generations on4descendants
- K993174Sysmex Automated Coagulation Analyzer, Model CA-6000Dade Behring, Inc. · 1999 · 2 generations on2descendants
- K970431Behring Coagulation SystemBehring Diagnostics, Inc. · 1997 · cites it directly2descendants
- K020979Sysmex Automated Coagulation Analyzer, Model #CA-7000Dade Behring, Inc. · 2002 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K926551 | Behring Fibrintimer a | Behring Diagnostics, Inc. | 1995 | — |
| +1 | K955278 | Behring Coagulation Timer | Behring Diagnostics, Inc. | 1996 | — |
| +2 | K992321 | Sysmex Automated Coagulation Analyzer, Model CA-6000 | Dade Behring, Inc. | 1999 | — |
| +2 | K993174 | Sysmex Automated Coagulation Analyzer, Model CA-6000 | Dade Behring, Inc. | 1999 | — |
| +1 | K970431 | Behring Coagulation System | Behring Diagnostics, Inc. | 1997 | 2 |
| +2 | K020979 | Sysmex Automated Coagulation Analyzer, Model #CA-7000 | Dade Behring, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 6 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2016 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 113 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, K955278 (Behring Diagnostics, Inc., 1996) has gone furthest, with 10 descendants of its own.
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 | — |
https://510kreport.com/device/K926551 · printed Nov 6, 2026
Cite this page
510(k) Report. “K926551: Behring Fibrintimer a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926551
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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