510(k) · Cleared
ClearedHemosil Factor Xii 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 Feb 9, 2005 as substantially equivalent to K893534 (Medical Diagnostic Technologies, Inc., 1989) and 1 other predicate after a 56-day review. Its family tree reaches back 1 generation to 1989. 1 later device descends from it.
- Decided
- Feb 9, 2005
- Review
- 56 days
- Class
- Class II
- Product code
- GJT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K893534 (1989). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK893534 Factor Xii Deficient PlasmaMedical Diagnostic Technologies, Inc. · 1989
- This deviceK043459 Hemosil Factor Xii Deficient PlasmaInstrumentation Laboratory CO · 2005
- Descendant · cites it directly · 0 of its ownK180486 HemosIL Factor XII Deficient PlasmaInstrumentation Laboratory CO · 2018
Most influential descendants
Showing 1 of 1 · See all- K180486HemosIL Factor XII Deficient PlasmaInstrumentation Laboratory CO · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K893534 | Factor Xii Deficient Plasma | Medical Diagnostic Technologies, Inc. | 1989 | — |
| 0 (this device) | K043459 | Hemosil Factor Xii Deficient Plasma | Instrumentation Laboratory CO | 2005 | — |
| +1 | K180486 | HemosIL Factor XII Deficient Plasma | Instrumentation Laboratory CO | 2018 | — |
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 |
|---|---|---|
| 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 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 |
|---|---|---|---|
| * | K893534 | Factor Xii Deficient PlasmaSummary page 1…ction: Factor Deficiency Test (864.7290) Classification: Class II Product Code: GJT Panel: Hematology Identification of Predicate Device(s): K893534 Hemnoliance Factor XII Deficient Plasma on ELECTRA Series Analyzers K002400 HemnosEL Factor XII Defi… | 1989 |
| * | K002400 | Modification of Acl AdvanceSummary page 1…GJT Panel: Hematology Identification of Predicate Device(s): K893534 Hemnoliance Factor XII Deficient Plasma on ELECTRA Series Analyzers K002400 HemnosEL Factor XII Deficient Plasma* on ACL Family of Analyzers *NOTE: FDA cleared as part… | 2000 |
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 |
|---|---|---|---|
| K180486 | HemosIL Factor XII Deficient Plasma | 2018 | 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?
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?
HemosfL Factor XI1 Deficient Plasma is human plasma immunodepleted of factor XH and intended for the in vitro diagnostic quantitative determination of factor XH activity in citrated plasma, based on the activated partial thromboplastin time (APIT) assay, on IL Coagulation and ELECTRA Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043459: Hemosil Factor Xii 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/K043459
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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