510(k) Report

510(k) · Cleared

Cleared

Berichrom Antithrombin Iii (a)

K933125510(k) TraditionalCleared Apr 19, 1994295-day reviewClass II21 CFR 864.7060

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

Behring Diagnostics, Inc. · JPE Antithrombin Iii, Two Stage Clotting Time Assay

Cleared on Apr 19, 1994 after a 295-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Apr 19, 1994
Review
295 days
Class
Class II
Product code
JPE
Recalls
None
Predicates
0

4 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared1996: 1 descendant cleared2025: 1 descendant cleared2003: 1 descendant cleared1990200020102020
  1. This deviceK933125 Berichrom Antithrombin Iii (a)Behring Diagnostics, Inc. · 1994
  2. Descendant · cites it directly · 1 of its ownK963292 Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1996 · Recalled
  3. Descendant · cites it directly · 0 of its ownK242952 INNOVANCE AntithrombinSiemens Healthcare Diagnostic Products GmbH · 2025
  4. Descendant · cites it directly · 0 of its ownK081769 Innovance Antithrombin with Models OPFH03, OPFHO5Siemens Healthcare Diagnostics · 2009
  5. Descendant · 2 generations on · 0 of its ownK031650 Ferritin Generation 2Roche Diagnostics Corp. · 2003

Most influential descendants

Showing 4 of 4 · See all
  • K963292Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc. · 1996 · cites it directly1descendant
  • K242952INNOVANCE AntithrombinSiemens Healthcare Diagnostic Products GmbH · 2025 · cites it directly0descendants
  • K081769Innovance Antithrombin with Models OPFH03, OPFHO5Siemens Healthcare Diagnostics · 2009 · cites it directly0descendants
  • K031650Ferritin Generation 2Roche Diagnostics Corp. · 2003 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K933125Berichrom Antithrombin Iii (a)Behring Diagnostics, Inc.1994—
+1K963292Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc.19962
+1K242952INNOVANCE AntithrombinSiemens Healthcare Diagnostic Products GmbH2025—
+1K081769Innovance Antithrombin with Models OPFH03, OPFHO5Siemens Healthcare Diagnostics2009—
+2K031650Ferritin Generation 2Roche Diagnostics Corp.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
200310
200910
202510
FIG. 1 — Lineage of K933125, 1994–2025Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JPE? 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
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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? (4)

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

NumberDeviceApplicantDecidedDescendants
K963292Cobas Integra Reagent Cassettes & Ancillary ReagentsRoche Diagnostic Systems, Inc.19961
K242952INNOVANCE AntithrombinSiemens Healthcare Diagnostic Products GmbH20250
K081769Innovance Antithrombin with Models OPFH03, OPFHO5Siemens Healthcare Diagnostics20090

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, K963292 (Roche Diagnostic Systems, Inc., 1996) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JPE devices

JPE Antithrombin Iii, Two Stage Clotting Time Assay: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JPE

FDA has decided no JPE device since 2007.

Median 510(k) review, days · JPE

Too few JPE 510(k)s in any year since 2007 to give a median.

Recalls per year · JPE

No recall names JPE since 2007.

Adverse event reports per year · JPE

2in 2024

2015: 12017: 12024: 2
2007high 2 (2024) · low 0 (2007)2025

MAUDE reports naming product code JPE, 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
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—01
20160—00
20170—01
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—02
20250—00
20260—0—

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

https://510kreport.com/device/K933125 · printed Nov 6, 2026

Cite this page

510(k) Report. “K933125: Berichrom Antithrombin Iii (a).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933125

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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