510(k) · Cleared
ClearedCoagulation Reference Plasma, Normal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Diagnostic Technologies, Inc. · GIZ Plasma, Control, Normal
Cleared on Dec 28, 1990 after a 38-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Dec 28, 1990
- Review
- 38 days
- Class
- Class II
- Product code
- GIZ
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK905203 Coagulation Reference Plasma, NormalMedical Diagnostic Technologies, Inc. · 1990
- Descendant · cites it directly · 4 of its ownK041905 Hemosil Calibration PlasmaInstrumentation Laboratory CO · 2004
- Descendant · 2 generations on · 1 of its ownK090563 Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software)Instrumentation Laboratory CO · 2009
- Descendant · 2 generations on · 0 of its ownK173202 CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator…Sekisui Medical Co., Ltd. · 2018
- Descendant · 3 generations on · 0 of its ownK093848 PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK092113 Sta - Free PS CalibratorDiagnostica Stago, Inc. · 2009
Most influential descendants
Showing 5 of 5 · See all- K041905Hemosil Calibration PlasmaInstrumentation Laboratory CO · 2004 · cites it directly4descendants
- K090563Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software)Instrumentation Laboratory CO · 2009 · 2 generations on1descendant
- K173202CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control SetSekisui Medical Co., Ltd. · 2018 · 2 generations on0descendants
- K093848PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc. · 2010 · 3 generations on0descendants
- K092113Sta - Free PS CalibratorDiagnostica Stago, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K905203 | Coagulation Reference Plasma, Normal | Medical Diagnostic Technologies, Inc. | 1990 | — |
| +1 | K041905 | Hemosil Calibration Plasma | Instrumentation Laboratory CO | 2004 | — |
| +2 | K090563 | Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software) | Instrumentation Laboratory CO | 2009 | — |
| +2 | K173202 | CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia… | Sekisui Medical Co., Ltd. | 2018 | — |
| +3 | K093848 | PT-Multi-Calibrator, Model OPAT07 | Dade Behring, Inc. | 2010 | — |
| +2 | K092113 | Sta - Free PS Calibrator | Diagnostica Stago, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2018 | 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 GIZ? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041905 | Hemosil Calibration Plasma | 2004 | 4 |
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, K041905 (Instrumentation Laboratory CO, 2004) has gone furthest, with 4 descendants of its own.
How does its category compare?
All GIZ devicesGIZ Plasma, Control, Normal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GIZ
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · GIZ
Too few GIZ 510(k)s in any year since 2007 to give a median.
Recalls per year · GIZ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GIZ
No MAUDE report names GIZ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 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 | — | 0 | — |
https://510kreport.com/device/K905203 · printed Nov 6, 2026
Cite this page
510(k) Report. “K905203: Coagulation Reference Plasma, Normal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K905203
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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