510(k) · Cleared
ClearedHemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · GGN Plasma, Coagulation Control
Cleared on Oct 9, 2009 as substantially equivalent to K010750 (Fisher Diagnostics, 2001) and 1 other predicate after a 221-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- Oct 9, 2009
- Review
- 221 days
- Class
- Class II
- Product code
- GGN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K905203 (1990). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK905203 Coagulation Reference Plasma, NormalMedical Diagnostic Technologies, Inc. · 1990
- 1 generation backK041905 Hemosil Calibration PlasmaInstrumentation Laboratory CO · 2004
- This deviceK090563 Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software)Instrumentation Laboratory CO · 2009
- Descendant · cites it directly · 0 of its ownK093848 PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc. · 2010
Most influential descendants
Showing 1 of 1 · See all- K093848PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K905203 | Coagulation Reference Plasma, Normal | Medical Diagnostic Technologies, Inc. | 1990 | — |
| −1 | K041905 | Hemosil Calibration Plasma | Instrumentation Laboratory CO | 2004 | — |
| 0 (this device) | K090563 | Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software) | Instrumentation Laboratory CO | 2009 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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? (2)
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 |
|---|---|---|---|
| * | K010750 | Pacific Hemostasis Inr Control Plasmas, Model Catalog 100560Summary page 1…GGN 21 CFR 864.5425 Calibrators: Class II Product Code: JIS 21 CFR 862.1150 Predicate Devices: HemoslL INR Validate K010750 Pacific Hemostasis INR Control Plasmas HemosIL ISI Calibrate K041905 HemosIL Calibration Plasma Device Inte… | 2001 |
| * | K041905 | Hemosil Calibration PlasmaSummary page 1…ode: JIS 21 CFR 862.1150 Predicate Devices: HemoslL INR Validate K010750 Pacific Hemostasis INR Control Plasmas HemosIL ISI Calibrate K041905 HemosIL Calibration Plasma Device Intended Uses: * HemosIL INR Validate is a tri-level quality control intended to monit… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093848 | PT-Multi-Calibrator, Model OPAT07 | 2010 | 0 |
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 19 years and passes through 2 companies; a new generation was cleared every 13.8 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K093848 (Dade Behring, Inc., 2010) has gone furthest, with 0 descendants 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. 2009, 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?
HemosIL INR Validate is a tri-level quality control intended to monitor the accuracy of INR (International Normalized Ratio) reporting with designated HemosIL PT reagents on IL Coagulation Systems in conjunction with the ISIweb software. * HemosIL ISI Calibrate is a set of four certified plasmas intended to establish a laboratory's instrument/ reagent specific local ISI (International Sensitivity Index) and Mean Normal Prothrombin Time (MNPT) with…
Read the full statement (126 words)
HemosIL INR Validate is a tri-level quality control intended to monitor the accuracy of INR (International Normalized Ratio) reporting with designated HemosIL PT reagents on IL Coagulation Systems in conjunction with the ISIweb software.
* HemosIL ISI Calibrate is a set of four certified plasmas intended to establish a laboratory's instrument/ reagent specific local ISI (International Sensitivity Index) and Mean Normal Prothrombin Time (MNPT) with designated HemosIL PT reagents on IL Coagulation Systems in conjunction with the ISIweb software.
· ISIweb Software is a web-based service to customers, used in conjunction with HemosIL INR Validate and HemosIL ISI Calibrate with designated HemosIL PT reagents on IL Coagulation Systems, whereby the PT seconds and INR results can be entered and calculated through a web-based interface (ISIweb software).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090563 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090563: Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090563
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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