510(k) · Cleared
ClearedFactor Viii Deficient Plasma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Diagnostic Technologies, Inc. · GJT Plasma, Coagulation Factor Deficient
Cleared on Jun 23, 1989 after a 46-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Jun 23, 1989
- Review
- 46 days
- Class
- Class II
- Product code
- GJT
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK893525 Factor Viii Deficient PlasmaMedical Diagnostic Technologies, Inc. · 1989
- Descendant · cites it directly · 2 of its ownK034007 Hemosil Factor Viii Deficient PlasmaInstrumentation Laboratory CO · 2004
- Descendant · 2 generations on · 1 of its ownK110237 Hemosil Factor Viii Deficient PlasmaInstrumentation Laboratory CO · 2011
- Descendant · 3 generations on · 0 of its ownK222831 CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK990046 Pacific Hemostasis Immunodepleted Factor Viii Deficient PlasmaPacific Hemostasis · 1999
- Descendant · cites it directly · 0 of its ownK961929 Factor Deficient PlasmaUniversal Reagents, Inc. · 1996
Most influential descendants
Showing 5 of 5 · See all- K034007Hemosil Factor Viii Deficient PlasmaInstrumentation Laboratory CO · 2004 · cites it directly2descendants
- K110237Hemosil Factor Viii Deficient PlasmaInstrumentation Laboratory CO · 2011 · 2 generations on1descendant
- K222831CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic, Inc. · 2023 · 3 generations on0descendants
- K990046Pacific Hemostasis Immunodepleted Factor Viii Deficient PlasmaPacific Hemostasis · 1999 · cites it directly0descendants
- K961929Factor Deficient PlasmaUniversal Reagents, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K893525 | Factor Viii Deficient Plasma | Medical Diagnostic Technologies, Inc. | 1989 | — |
| +1 | K034007 | Hemosil Factor Viii Deficient Plasma | Instrumentation Laboratory CO | 2004 | — |
| +2 | K110237 | Hemosil Factor Viii Deficient Plasma | Instrumentation Laboratory CO | 2011 | — |
| +3 | K222831 | CRYOcheck Factor VIII Deficient Plasma with VWF | Precision Biologic, Inc. | 2023 | — |
| +1 | K990046 | Pacific Hemostasis Immunodepleted Factor Viii Deficient Plasma | Pacific Hemostasis | 1999 | — |
| +1 | K961929 | Factor Deficient Plasma | Universal Reagents, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2011 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
3 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?
- Of its descendants, K034007 (Instrumentation Laboratory CO, 2004) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K893525 · printed Nov 4, 2026
Cite this page
510(k) Report. “K893525: Factor Viii Deficient Plasma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K893525
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026