510(k) Report

510(k) · Cleared

Cleared

Calibration Plasma LMW Heparin

K030964510(k) TraditionalCleared Jun 6, 200371-day reviewClass II21 CFR 862.1150

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

Instrumentation Laboratory CO · JIS Calibrator, Primary

Cleared on Jun 6, 2003 as substantially equivalent to K002400 (Instrumentation Laboratory CO, 2000) after a 71-day review. Its family tree reaches back 1 generation to 2000. 7 later devices descend from it.

Decided
Jun 6, 2003
Review
71 days
Class
Class II
Product code
JIS
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K002400 (2000). 7 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2009: 2 descendants cleared2005: 1 descendant cleared2022: 1 descendant cleared2017: 1 descendant cleared2023: 1 descendant cleared2024: 1 descendant clearedK002400 · Modification of Acl Advance · Instrumentation Laboratory CO · 2000 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants K002400 · Modification of Acl Advance · Instrumentation Laboratory CO · 2000 · recalled0
  1. Root · 1 generation backK002400 Modification of Acl AdvanceInstrumentation Laboratory CO · 2000 · Recalled
  2. This deviceK030964 Calibration Plasma LMW HeparinInstrumentation Laboratory CO · 2003
  3. Descendant · cites it directly · 4 of its ownK090209 Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin…Instrumentation Laboratory CO · 2009 · Recalled
  4. Descendant · 2 generations on · 2 of its ownK213464 HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2022 · Recalled
  5. Descendant · 3 generations on · 1 of its ownK223187 HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2023
  6. Descendant · 3 generations on · 0 of its ownK240315 INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05)…Siemens Healthcare Diagnostics Products GmbH · 2024
  7. Descendant · 2 generations on · 0 of its ownK163498 VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLC · 2017

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2005: 12009: 22017: 12022: 12023: 12024: 1
2005high 2 (2009) · low 0 (2006)2026

Most influential descendants

Showing 5 of 7 · See all
  • K090209Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin ControlsInstrumentation Laboratory CO · 2009 · cites it directly4descendants
  • K213464HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2022 · 2 generations on2descendants
  • K223187HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2023 · 3 generations on1descendant
  • K240315INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban…Siemens Healthcare Diagnostics Products GmbH · 2024 · 3 generations on0descendants
  • K163498VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLC · 2017 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002400Modification of Acl AdvanceInstrumentation Laboratory CO20002
0 (this device)K030964Calibration Plasma LMW HeparinInstrumentation Laboratory CO2003—
+1K090209Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin ControlsInstrumentation Laboratory CO20095
+2K213464HemosIL Liquid Anti-XaInstrumentation Laboratory CO20222
+3K223187HemosIL Liquid Anti-XaInstrumentation Laboratory CO2023—
+3K240315INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE…Siemens Healthcare Diagnostics Products GmbH2024—
+2K163498VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLC2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200920
201710
202210
202310
202410
FIG. 1 — Lineage of K030964, 2000–2024Source: 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 JIS? 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? (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
*K002400Modification of Acl AdvanceInstrumentation Laboratory CO20002

Also cleared against K002400: 13 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K090209Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin ControlsInstrumentation Laboratory CO20094
K083159Berichrom Heparin LMW Calibrator, Berichrom Heparin LMW Control 1, and Berichrom Heparin…Siemens Healthcare Diagnostics20090
K051472Biophen LMWH Control, LMWH Control Low, Ufh Control, Heparin Calibrator & Ufh CalibratorHyphen Biomed20050

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 a recall.
  • Of its descendants, K090209 (Instrumentation Laboratory CO, 2009) has gone furthest, with 4 descendants of its own.
  • 13 other devices also cite its predicate K002400.

How does its category compare?

All JIS devices

JIS Calibrator, Primary: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JIS

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JIS

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

Recalls per year · JIS

1in 2022

2008: 12011: 22012: 12016: 12018: 12020: 12021: 12022: 1
2007high 2 (2011) · low 0 (2007)2026

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

Adverse event reports per year · JIS

1in 2024

2010: 12011: 52012: 52013: 12015: 12016: 12017: 32018: 72019: 12020: 12022: 112024: 1
2007high 11 (2022) · low 0 (2007)2025

MAUDE reports naming product code JIS, 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—10
20090—00
20100—01
20110—25
20121—15
20130—01
20140—00
20150—01
20160—11
20170—03
20180—17
20190—01
20200—11
20210—10
20220—111
20230—00
20240—01
20250—00
20260—0—

What is it indicated for?

Calibration Plasma LMW Heparin is an in vitro diagnostic product intended as a tri-level calibrator to prepare calibration curves for use in chromogenic heparin assays.

Indications for use as stated in the FDA summary.

Also cleared against K002400

13 other devices cite the same predicate.

  • K050661Hemosil Factor II Deficient PlasmaInstrumentation Laboratory CO · 2005
  • K043459Hemosil Factor Xii Deficient PlasmaInstrumentation Laboratory CO · 2005
  • K043184Hemosil RecombiplastinInstrumentation Laboratory CO · 20041 recall
  • K041905Hemosil Calibration PlasmaInstrumentation Laboratory CO · 2004
  • K034007Hemosil Factor Viii Deficient PlasmaInstrumentation Laboratory CO · 2004
  • K033414Acl Top Model, TopInstrumentation Laboratory CO · 20041 recall

More from Instrumentation Laboratory CO

321 FDA decisions under this applicant name. See the company

  • K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMInstrumentation Laboratory CO · 2023
  • K223187HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2023
  • K223090GEM Premier ChemSTATInstrumentation Laboratory CO · 2023
  • K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO · 2022
  • K213464HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 20222 recalls

Recent decisions in JIS

The JIS category page

  • K122126Direct LDL/HDL Cholesterol CalibratorRandox Laboratories Limited · 2012
  • K061251Dimension Vista Total Iron Binding Capacity CalibratorDade Behring, Inc. · 2006
  • K060266Dimension Iron CalibratorDade Behring, Inc. · 20061 recall
  • K053104Dimension Cardiophase High Sensitivity C-Reactive Protein CalibratorDade Behring, Inc. · 2005
  • K032697Dimension Total Triiodothyronine Calibrator (RC414)Dade Behring, Inc. · 2003

https://510kreport.com/device/K030964 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030964: Calibration Plasma LMW Heparin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030964

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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