510(k) · Cleared
ClearedUniversal Reagent Factor Vii Deficient Plasma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Universal Reagents, Inc. · GJT Plasma, Coagulation Factor Deficient
Cleared on Apr 25, 1997 as substantially equivalent to K883692 (Ortho Diagnostic Systems, Inc., 1988) after a 66-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Apr 25, 1997
- Review
- 66 days
- Class
- Class II
- Product code
- GJT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K883692 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK883692 Ortho Factor Vii Deficient PlasmaOrtho Diagnostic Systems, Inc. · 1988
- This deviceK970607 Universal Reagent Factor Vii Deficient PlasmaUniversal Reagents, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883692 | Ortho Factor Vii Deficient Plasma | Ortho Diagnostic Systems, Inc. | 1988 | — |
| 0 (this device) | K970607 | Universal Reagent Factor Vii Deficient Plasma | Universal Reagents, Inc. | 1997 | — |
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? (1)
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 |
|---|---|---|---|
| * | K883692 | Ortho Factor Vii Deficient PlasmaSummary page 1…ve and Quantitative Factor Deficiency Test - VII Qualitative and Quantitative Factor Deficiency Test Factor deficient coagulation plasma - VI Ortho Diagnostic Systems - K883692 - Factor Vil Factor deficient plasma to be free of antigen of Factor Vil utilized in in vitro diagnostic use. Indicated use - F… | 1988 |
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?
- Its one ancestor has no recall.
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?
Factor deficient plasma, Factor - VII is a human plasma immunodepleted of the specific factor and intended for use in the quantitative determination of the specific levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970607 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970607: Universal Reagent Factor Vii 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/K970607
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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