510(k) Report

510(k) · Cleared

Cleared

Behring Coagulation Timer

K955278510(k) TraditionalCleared May 30, 1996195-day reviewClass II21 CFR 864.5425

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Behring Diagnostics, Inc. · GGN Plasma, Coagulation Control

Cleared on May 30, 1996 as substantially equivalent to K926551 (Behring Diagnostics, Inc., 1995) after a 195-day review. Its family tree reaches back 1 generation to 1995. 10 later devices descend from it.

Decided
May 30, 1996
Review
195 days
Class
Class II
Product code
GGN
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K926551 (1995). 10 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 1999: 6 descendants cleared1997: 1 descendant cleared2002: 1 descendant cleared2016: 1 descendant cleared2003: 1 descendant clearedReference device: K901829 · Behring Chromotimer · Behring Diagnostics, Inc. · 1990K926551 · Behring Fibrintimer a · Behring Diagnostics, Inc. · 19951995200020052010201520202025
Descendants, by generation 1 generation forward: 7 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant K926551 · Behring Fibrintimer a · Behring Diagnostics, Inc. · 19950
  1. Root · 1 generation backK926551 Behring Fibrintimer aBehring Diagnostics, Inc. · 1995
  2. This deviceK955278 Behring Coagulation TimerBehring Diagnostics, Inc. · 1996
  3. Descendant · cites it directly · 4 of its ownK992321 Sysmex Automated Coagulation Analyzer, Model CA-6000Dade Behring, Inc. · 1999
  4. Descendant · cites it directly · 2 of its ownK993174 Sysmex Automated Coagulation Analyzer, Model CA-6000Dade Behring, Inc. · 1999
  5. Descendant · cites it directly · 2 of its ownK970431 Behring Coagulation SystemBehring Diagnostics, Inc. · 1997 · Recalled
  6. Descendant · 2 generations on · 1 of its ownK020979 Sysmex Automated Coagulation Analyzer, Model #CA-7000Dade Behring, Inc. · 2002
  7. Descendant · cites it directly · 1 of its ownK993299 Sysmex Automated Coagulation Analyzer, Model CA-1500Dade Behring, Inc. · 1999

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

1997: 11999: 62002: 12003: 12016: 1
1997high 6 (1999) · low 0 (1998)2026

Most influential descendants

Showing 5 of 10 · See all
  • K992321Sysmex Automated Coagulation Analyzer, Model CA-6000Dade Behring, Inc. · 1999 · cites it directly4descendants
  • K993174Sysmex Automated Coagulation Analyzer, Model CA-6000Dade Behring, Inc. · 1999 · cites it directly2descendants
  • K970431Behring Coagulation SystemBehring Diagnostics, Inc. · 1997 · cites it directly2descendants
  • K020979Sysmex Automated Coagulation Analyzer, Model #CA-7000Dade Behring, Inc. · 2002 · 2 generations on1descendant
  • K993299Sysmex Automated Coagulation Analyzer, Model CA-1500Dade Behring, Inc. · 1999 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K926551Behring Fibrintimer aBehring Diagnostics, Inc.1995—
0 (this device)K955278Behring Coagulation TimerBehring Diagnostics, Inc.1996—
+1K992321Sysmex Automated Coagulation Analyzer, Model CA-6000Dade Behring, Inc.1999—
+1K993174Sysmex Automated Coagulation Analyzer, Model CA-6000Dade Behring, Inc.1999—
+1K970431Behring Coagulation SystemBehring Diagnostics, Inc.19972
+2K020979Sysmex Automated Coagulation Analyzer, Model #CA-7000Dade Behring, Inc.2002—
+1K993299Sysmex Automated Coagulation Analyzer, Model CA-1500Dade Behring, Inc.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199960
200210
200310
201610
FIG. 1 — Lineage of K955278, 1995–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 GGN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K926551Behring Fibrintimer a
Summary page 2
…The Behring Coagulation Timer (BCT) is substantially equivalent in intended use and results obtained to the Behring Fibrintimer A (BFA) which was the subject of 510(k) K926551 . The BCT like the BFA performs fully automatic, rapid quantitative measurement of coagulation time by optical detection. Both an…
Behring Diagnostics, Inc.1995—
†K901829Behring ChromotimerBehring Diagnostics, Inc.1990—

Also cleared against K926551: 2 other devices →

What descends from it? (10)

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K992321Sysmex Automated Coagulation Analyzer, Model CA-6000Dade Behring, Inc.19994
K993174Sysmex Automated Coagulation Analyzer, Model CA-6000Dade Behring, Inc.19992
K970431Behring Coagulation SystemBehring Diagnostics, Inc.19972
K993299Sysmex Automated Coagulation Analyzer, Model CA-1500Dade Behring, Inc.19991
K992423Sysmex Automated Coagulation Analyzer, Model CA-500Dade Behring, Inc.19990
K992763Sysmex Automated Coagulation Analyzer, Model CA-500Dade Behring, Inc.19990
K984501Dade Behring BftiiDade Behring, Inc.19990

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?

  • Its one ancestor has no recall.
  • Of its descendants, K992321 (Dade Behring, Inc., 1999) has gone furthest, with 4 descendants of its own.
  • 2 other devices also cite its predicate K926551.

How does its category compare?

All GGN devices

GGN Plasma, Coagulation Control: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GGN

4in 2017

2007: 32008: 12009: 22010: 32011: 22012: 12013: 32014: 22016: 22017: 4
2007high 4 (2017) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GGN

96in 2017

2007: 47 days median2010: 23 days median2013: 441 days median2017: 96 days median
2007high 441 (2013) · low 23 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GGN

1in 2019

2010: 42011: 12013: 32019: 12026 (partial year): 2
2007high 4 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GGN

4in 2018

2009: 372010: 172011: 302012: 102013: 92014: 52015: 102016: 92017: 112018: 4
2007high 37 (2009) · low 0 (2007)2025

MAUDE reports naming product code GGN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200734700
20081—00
20092—037
2010323417
20112—130
20121—010
2013344139
20142—05
20150—010
20162—09
2017496011
20180—04
20190—10
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—2—

What is it indicated for?

Behring Coagulation Timer is a photometric coagulation analyzer intended for clinical use to perform all coagulometric, chromogenic and immunologic coagulation tests.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K926551

2 other devices cite the same predicate.

  • K992423Sysmex Automated Coagulation Analyzer, Model CA-500Dade Behring, Inc. · 1999
  • K970431Behring Coagulation SystemBehring Diagnostics, Inc. · 19972 recalls

More from Behring Diagnostics, Inc.

146 FDA decisions under this applicant name. See the company

  • K973832Opus HLH ControlsBehring Diagnostics, Inc. · 1997
  • K972929N Antiserum to Human AlbuminBehring Diagnostics, Inc. · 1997
  • K972840N Antiserum to Human TransferrinBehring Diagnostics, Inc. · 1997
  • K973202Modification of Opus Ferritin Test SystemBehring Diagnostics, Inc. · 1997
  • K972316Opus D-DimerBehring Diagnostics, Inc. · 1997

Recent decisions in GGN

The GGN category page

  • K170864VALIDATE D-Dimer Calibration Verification / Linearity Test KitMaine Standards Company, LLC · 2017
  • K163498VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLC · 2017
  • K161316George King Coumadin PlasmaGeorge King Bio-Medical, Inc. · 2017
  • K162705VALIDATE® D-Dimer Calibration Verification/ Linearity Test KitMaine Standards Company, LLC · 2017
  • K152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLC · 2016

https://510kreport.com/device/K955278 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955278: Behring Coagulation Timer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955278

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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