510(k) · Cleared
ClearedHemosil Factor Viii 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 13, 2004 as substantially equivalent to K893525 (Medical Diagnostic Technologies, Inc., 1989) and 1 other predicate after a 51-day review. Its family tree reaches back 1 generation to 1989. 2 later devices descend from it.
- Decided
- Feb 13, 2004
- Review
- 51 days
- Class
- Class II
- Product code
- GJT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K893525 (1989). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK893525 Factor Viii Deficient PlasmaMedical Diagnostic Technologies, Inc. · 1989
- This deviceK034007 Hemosil Factor Viii Deficient PlasmaInstrumentation Laboratory CO · 2004
- Descendant · cites it directly · 1 of its ownK110237 Hemosil Factor Viii Deficient PlasmaInstrumentation Laboratory CO · 2011
- Descendant · 2 generations on · 0 of its ownK222831 CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic, Inc. · 2023
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 | K893525 | Factor Viii Deficient Plasma | Medical Diagnostic Technologies, Inc. | 1989 | — |
| 0 (this device) | K034007 | Hemosil Factor Viii Deficient Plasma | Instrumentation Laboratory CO | 2004 | — |
| +1 | K110237 | Hemosil Factor Viii Deficient Plasma | Instrumentation Laboratory CO | 2011 | — |
| +2 | K222831 | CRYOcheck Factor VIII Deficient Plasma with VWF | Precision Biologic, Inc. | 2023 | — |
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 |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K893525 | Factor Viii Deficient PlasmaSummary page 1…tion Name(s): 864.7290 Factor Deficiency Tests Class HI 81GJT Plasma, Coagulation Factor Deficient Identification of Predicate Device(s): K893525 Hemoliance Factor VIII Deficient Plasma on ELECTRA Series Analyzers K002400 IL Test Factor VIII Deficient Plasma* on ACL F… | 1989 |
| * | K002400 | Modification of Acl AdvanceSummary page 1…Plasma, Coagulation Factor Deficient Identification of Predicate Device(s): K893525 Hemoliance Factor VIII Deficient Plasma on ELECTRA Series Analyzers K002400 IL Test Factor VIII Deficient Plasma* on ACL Family of Analyzers *NOTE: Reagent was 510(k) cleared as part of mult… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110237 | Hemosil Factor Viii Deficient Plasma | 2011 | 1 |
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 VIII Deficient Plasma is human plasma immunodepleted of factor VIII and intended for the in vitro diagnostic quantitative determination of factor VIII 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/K034007 · printed Nov 3, 2026
Cite this page
510(k) Report. “K034007: Hemosil Factor Viii Deficient Plasma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K034007
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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