510(k) · Cleared
ClearedHemosil Factor II 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 May 2, 2005 as substantially equivalent to K900133 (Medical Diagnostic Technologies, Inc., 1990) and 1 other predicate after a 48-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- May 2, 2005
- Review
- 48 days
- Class
- Class II
- Product code
- GJT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K900133 (1990). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK900133 Factor II Deficient PlasmaMedical Diagnostic Technologies, Inc. · 1990
- This deviceK050661 Hemosil Factor II Deficient PlasmaInstrumentation Laboratory CO · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900133 | Factor II Deficient Plasma | Medical Diagnostic Technologies, Inc. | 1990 | — |
| 0 (this device) | K050661 | Hemosil Factor II Deficient Plasma | Instrumentation Laboratory CO | 2005 | — |
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 |
|---|---|---|---|
| * | K900133 | Factor II Deficient PlasmaSummary page 1…ion Section: Factor Deficiency Test (864.7290) Classification: Class 11 Product Code: GJT Panel: Hematology Identification of Predicate Device(s): K900133 Hemoliance Factor II Deficient Plasma on ELECTRA Series Analyzers K002400 HemoslL Factor IIDeficien… | 1990 |
| * | K002400 | Modification of Acl AdvanceSummary page 1…GJT Panel: Hematology Identification of Predicate Device(s): K900133 Hemoliance Factor II Deficient Plasma on ELECTRA Series Analyzers K002400 HemoslL Factor IIDeficient Plasma* on ACL Family of Analyzers *NOTE: FDA cleared as part of… | 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 K900133.
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 II Deficient Plasma is human plasma immunodepleted of factor II and intended for the in vitro diagnostic quantitative determination of factor II activity in citrated plasma, based on the prothrombin time (PT) assay, on IL Coagulation and ELECTRA Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050661: Hemosil Factor II 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/K050661
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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