510(k) · Cleared
ClearedHemosil Calibration Plasma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · JIX Calibrator, Multi-Analyte Mixture
Cleared on Sep 28, 2004 as substantially equivalent to K905203 (Medical Diagnostic Technologies, Inc., 1990) and 1 other predicate after a 75-day review. Its family tree reaches back 1 generation to 1990. 4 later devices descend from it.
- Decided
- Sep 28, 2004
- Review
- 75 days
- Class
- Class II
- Product code
- JIX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K905203 (1990). 2 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK905203 Coagulation Reference Plasma, NormalMedical Diagnostic Technologies, Inc. · 1990
- This deviceK041905 Hemosil Calibration PlasmaInstrumentation Laboratory CO · 2004
- Descendant · cites it directly · 1 of its ownK090563 Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software)Instrumentation Laboratory CO · 2009
- Descendant · cites it directly · 0 of its ownK173202 CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator…Sekisui Medical Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK093848 PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK092113 Sta - Free PS CalibratorDiagnostica Stago, Inc. · 2009
Most influential descendants
Showing 4 of 4 · See all- K090563Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software)Instrumentation Laboratory CO · 2009 · cites it directly1descendant
- K173202CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control SetSekisui Medical Co., Ltd. · 2018 · cites it directly0descendants
- K093848PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc. · 2010 · 2 generations on0descendants
- K092113Sta - Free PS CalibratorDiagnostica Stago, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905203 | Coagulation Reference Plasma, Normal | Medical Diagnostic Technologies, Inc. | 1990 | — |
| 0 (this device) | K041905 | Hemosil Calibration Plasma | Instrumentation Laboratory CO | 2004 | — |
| +1 | K090563 | Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (Software) | Instrumentation Laboratory CO | 2009 | — |
| +1 | K173202 | CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia… | Sekisui Medical Co., Ltd. | 2018 | — |
| +2 | K093848 | PT-Multi-Calibrator, Model OPAT07 | Dade Behring, Inc. | 2010 | — |
| +1 | K092113 | Sta - Free PS Calibrator | Diagnostica Stago, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2018 | 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 JIX? 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 |
|---|---|---|---|
| * | K905203 | Coagulation Reference Plasma, NormalSummary page 1…ication Name(s): 862.1150 Calibrator Class II JIX Calibrator, Multi-Analyte Mixture Identification of Predicate Device(s): K905203 HemosIL Assayed Reference Plasma-Normal (for ELECTRA Series Analyzers) K002400 Assess Calibration Plasma (for… | 1990 |
| * | K002400 | Modification of Acl AdvanceSummary page 1…Calibrator, Multi-Analyte Mixture Identification of Predicate Device(s): K905203 HemosIL Assayed Reference Plasma-Normal (for ELECTRA Series Analyzers) K002400 Assess Calibration Plasma (for ACL Family of Analyzers) NOTE: FDA cleared as part of the individual ACL… | 2000 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K090563 (Instrumentation Laboratory CO, 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JIX
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIX
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIX
18in 2025
MAUDE reports naming product code JIX, 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 | 6 | 53 | 2 | 140 |
| 2008 | 5 | 69 | 3 | 173 |
| 2009 | 4 | 121 | 2 | 39 |
| 2010 | 5 | 100 | 1 | 0 |
| 2011 | 7 | 77 | 2 | 9 |
| 2012 | 2 | — | 1 | 3 |
| 2013 | 4 | 50 | 0 | 24 |
| 2014 | 1 | — | 1 | 35 |
| 2015 | 3 | 29 | 0 | 4 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 1 | 17 |
| 2018 | 0 | — | 1 | 16 |
| 2019 | 0 | — | 1 | 12 |
| 2020 | 0 | — | 2 | 22 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 7 | 13 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
HemosIL Calibration plasma is intended for the calibration of coagulation assays on IL and ELECTRA Coagulation Systems. The calibration plasma is prepared using citrated plasma plasmapheresed from healthy donors to maintain the characteristics of a normal plasma pool.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041905 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041905: Hemosil Calibration Plasma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041905
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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