510(k) · Cleared
ClearedHemosil Factor XI 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 Mar 19, 2003 as substantially equivalent to K893536 (Medical Diagnostic Technologies, Inc., 1989) and 1 other predicate after a 50-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Mar 19, 2003
- Review
- 50 days
- Class
- Class II
- Product code
- GJT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K893536 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK893536 Factor XI Deficient PlasmaMedical Diagnostic Technologies, Inc. · 1989
- This deviceK030287 Hemosil Factor XI Deficient PlasmaInstrumentation Laboratory CO · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K893536 | Factor XI Deficient Plasma | Medical Diagnostic Technologies, Inc. | 1989 | — |
| 0 (this device) | K030287 | Hemosil Factor XI Deficient Plasma | Instrumentation Laboratory CO | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K893536 | Factor XI Deficient PlasmaSummary page 1…ame(s): 864.7290 Factor Deficiency Tests Class I1 81GJT Plasma, Coagulation Factor Deficient Identification of Predicate Device(s): K893536 Hemoliance Factor XI Deficient Plasma on ELECTRA Series Analyzers KO02400 IL Test Factor XI Deficient Plasma* on ACL Family of… | 1989 |
| * | K002400 | Modification of Acl Advance | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 1 other device also cites its predicate K893536.
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 XI Deficient Plasma is human plasma immunodepleted of factor XI and intended for the in vitro diagnostic quantitative determination of factor XI 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/K030287 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030287: Hemosil Factor XI 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/K030287
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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