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 Dec 1, 1992 after a 106-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Dec 1, 1992
- Review
- 106 days
- Class
- Class II
- Product code
- JPA
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK924124 Behring Fibrintimer aBehring Diagnostics, Inc. · 1992
- Descendant · cites it directly · 4 of its ownK992321 Sysmex Automated Coagulation Analyzer, Model CA-6000Dade Behring, Inc. · 1999
- Descendant · 2 generations on · 1 of its ownK020979 Sysmex Automated Coagulation Analyzer, Model #CA-7000Dade Behring, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK993299 Sysmex Automated Coagulation Analyzer, Model CA-1500Dade Behring, Inc. · 1999
- Descendant · 3 generations on · 0 of its ownK162420 Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH · 2016
- Descendant · 3 generations on · 0 of its ownK031377 Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520…Dade Behring, Inc. · 2003
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K992321Sysmex Automated Coagulation Analyzer, Model CA-6000Dade Behring, Inc. · 1999 · cites it directly4descendants
- K020979Sysmex Automated Coagulation Analyzer, Model #CA-7000Dade Behring, Inc. · 2002 · 2 generations on1descendant
- K993299Sysmex Automated Coagulation Analyzer, Model CA-1500Dade Behring, Inc. · 1999 · 2 generations on1descendant
- K162420Sysmex Automated Blood Coagulation Analyzer CS-5100Siemens Healthcare Diagnostics Products GmbH · 2016 · 3 generations on0descendants
- K031377Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520, -530, -540. -550, and…Dade Behring, Inc. · 2003 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924124 | Behring Fibrintimer a | Behring Diagnostics, Inc. | 1992 | — |
| +1 | K992321 | Sysmex Automated Coagulation Analyzer, Model CA-6000 | Dade Behring, Inc. | 1999 | — |
| +2 | K020979 | Sysmex Automated Coagulation Analyzer, Model #CA-7000 | Dade Behring, Inc. | 2002 | — |
| +2 | K993299 | Sysmex Automated Coagulation Analyzer, Model CA-1500 | Dade Behring, Inc. | 1999 | — |
| +3 | K162420 | Sysmex Automated Blood Coagulation Analyzer CS-5100 | Siemens Healthcare Diagnostics Products GmbH | 2016 | — |
| +3 | 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 |
|---|---|---|
| 1999 | 3 | 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? (6)
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, K992321 (Dade Behring, Inc., 1999) has gone furthest, with 4 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/K924124 · printed Nov 5, 2026
Cite this page
510(k) Report. “K924124: Behring Fibrintimer a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K924124
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026