510(k) · Cleared
ClearedPacific Hemostasis Inr Control Plasmas, Model Catalog 100560
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher Diagnostics · GGN Plasma, Coagulation Control
Cleared on Sep 7, 2001 after a 178-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Sep 7, 2001
- Review
- 178 days
- Class
- Class II
- Product code
- GGN
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK010750 Pacific Hemostasis Inr Control Plasmas, Model Catalog 100560Fisher Diagnostics · 2001
- Descendant · cites it directly · 1 of its ownK090563 Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software)Instrumentation Laboratory CO · 2009
- Descendant · 2 generations on · 0 of its ownK093848 PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc. · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010750 | Pacific Hemostasis Inr Control Plasmas, Model Catalog 100560 | Fisher Diagnostics | 2001 | — |
| +1 | K090563 | Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software) | Instrumentation Laboratory CO | 2009 | — |
| +2 | K093848 | PT-Multi-Calibrator, Model OPAT07 | Dade Behring, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090563 | Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software) | 2009 | 1 |
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, K090563 (Instrumentation Laboratory CO, 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GGN devicesGGN Plasma, Coagulation Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K010750 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010750: Pacific Hemostasis Inr Control Plasmas, Model Catalog 100560.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010750
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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