510(k) · Cleared
ClearedHemosil Factor IX Deficient Plasma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · GJT Plasma, Coagulation Factor Deficient
Cleared on Jul 31, 2003 as substantially equivalent to K893524 (Medical Diagnostic Technologies, Inc., 1989) and 1 other predicate after a 48-day review. Its family tree reaches back 1 generation to 1989. 2 later devices descend from it.
- Decided
- Jul 31, 2003
- Review
- 48 days
- Class
- Class II
- Product code
- GJT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K893524 (1989). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK893524 Factor IX Deficient PlasmaMedical Diagnostic Technologies, Inc. · 1989
- This deviceK031829 Hemosil Factor IX Deficient PlasmaInstrumentation Laboratory CO · 2003
- Descendant · cites it directly · 0 of its ownK230852 HemosIL Chromogenic Factor IXInstrumentation Laboratory Company · 2023
- Descendant · cites it directly · 0 of its ownK214002 CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc. · 2022
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 |
|---|---|---|---|---|---|
| −1 | K893524 | Factor IX Deficient Plasma | Medical Diagnostic Technologies, Inc. | 1989 | — |
| 0 (this device) | K031829 | Hemosil Factor IX Deficient Plasma | Instrumentation Laboratory CO | 2003 | — |
| +1 | K230852 | HemosIL Chromogenic Factor IX | Instrumentation Laboratory Company | 2023 | — |
| +1 | K214002 | CRYOcheck Chromogenic Factor IX | Precision Biologic, Inc. | 2022 | — |
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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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 GJT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GJT device
- #1 K222831 CRYOcheck Factor VIII Deficient Plasma with VWFscore 6.6 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K893524 | Factor IX Deficient PlasmaSummary page 1…n Name(s): 864.7290 Factor Deficiency Tests Class I1 81GJT Plasma, Coagulation Factor Deficient Identification of Predicate Device(s): K893524 Hemoliance Factor IX Deficient Plasma on ELECTRA Series Analyzers KO02400 IL Test Factor IX Deficient Plasma* on ACL Family of… | 1989 |
| * | K002400 | Modification of Acl Advance | 2000 |
What descends from it? (2)
2 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?
How does its category compare?
All GJT devicesGJT Plasma, Coagulation Factor Deficient: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GJT
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · GJT
444in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GJT
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GJT
1in 2025
MAUDE reports naming product code GJT, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 3 | 444 | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 3 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
HemosIL Factor IX Deficient Plasma is human plasma immunodepleted of factor IX and intended for the in vitro diagnostic quantitative determination of factor IX activity in citrated plasma, based on the activated partial thromboplastin time (APTT) assay, on IL Coagulation and ELECTRA Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031829 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031829: Hemosil Factor IX Deficient Plasma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031829
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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