510(k) · Cleared
ClearedPT-Multi-Calibrator, Model OPAT07
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · GGN Plasma, Coagulation Control
Cleared on Dec 20, 2010 as substantially equivalent to K090563 (Instrumentation Laboratory CO, 2009) after a 369-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Dec 20, 2010
- Review
- 369 days
- Class
- Class II
- Product code
- GGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K905203 (1990). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK905203 Coagulation Reference Plasma, NormalMedical Diagnostic Technologies, Inc. · 1990
- 2 generations backK041905 Hemosil Calibration PlasmaInstrumentation Laboratory CO · 2004
- 1 generation backK090563 Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software)Instrumentation Laboratory CO · 2009
- This deviceK093848 PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K905203 | Coagulation Reference Plasma, Normal | Medical Diagnostic Technologies, Inc. | 1990 | — |
| −2 | K041905 | Hemosil Calibration Plasma | Instrumentation Laboratory CO | 2004 | — |
| −1 | K090563 | Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software) | Instrumentation Laboratory CO | 2009 | — |
| 0 (this device) | K093848 | PT-Multi-Calibrator, Model OPAT07 | Dade Behring, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
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
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K090563 | Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software)Summary page 2…tional principles of the device. The PT-Multi Calibrator issubstantially equivalent in intended use to HemosiLl INR Validate®, HemoslL@- ISI Calibrate, ISI web Software (K090563), Instrumentation Laboratories Co., Lexington, MA 02421. Both devices are intended as calibrators for monitoring the accuracy and… | 2009 |
| * | — | HemosIL INR Validate® Named without a submission number | |
| * | — | HemosIL-ISI Calibrate Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All GGN devicesGGN Plasma, Coagulation Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · GGN
4in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · GGN
96in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GGN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GGN
4in 2018
MAUDE reports naming product code GGN, 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 | 3 | 47 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 37 |
| 2010 | 3 | 23 | 4 | 17 |
| 2011 | 2 | — | 1 | 30 |
| 2012 | 1 | — | 0 | 10 |
| 2013 | 3 | 441 | 3 | 9 |
| 2014 | 2 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 2 | — | 0 | 9 |
| 2017 | 4 | 96 | 0 | 11 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
Intended Use: PT-Multi Calibrator is intended as a calibrator set for local PT/INR calibration and/or local verification of the INR system for plasma based procedures with designated Siemens thromboplastins Dade® Innovin® or Thromborel® S on the BCS® BOS® XP Systems.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K093848 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093848: PT-Multi-Calibrator, Model OPAT07.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093848
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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