510(k) · Cleared
ClearedUniversal Reagent Factor X Deficient Plasma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Universal Reagents, Inc. · GGP Test, Qualitative And Quantitative Factor Deficiency
Cleared on Dec 18, 1996 as substantially equivalent to K843310 (Sigma Chemical Co., 1984) after a 41-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Dec 18, 1996
- Review
- 41 days
- Class
- Class II
- Product code
- GGP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K843310 (1984). No later device cites it as a predicate yet.
- Root · 1 generation backK843310 Factor X Deficient Plasma, Blod HumanSigma Chemical Co. · 1984
- This deviceK964459 Universal Reagent Factor X Deficient PlasmaUniversal Reagents, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K843310 | Factor X Deficient Plasma, Blod Human | Sigma Chemical Co. | 1984 | — |
| 0 (this device) | K964459 | Universal Reagent Factor X Deficient Plasma | Universal Reagents, Inc. | 1996 | — |
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 GGP? 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 GGP device
- #1 K251440 CRYOcheck Chromogenic Factor VIIIscore 10.5 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K843310 | Factor X Deficient Plasma, Blod HumanSummary page 1…n plasma - X Qualitative and Quantitative Factor Deficiency Test - X Qualitative and Quantitative Factor Deficiency Test Factor deficient coagulation plasma - X Sigma - K843310 - Factor X Factor deficient plasma to be free of antigen of Factor X utilized in in vitro diagnostic use. Indicated use - Facto… | 1984 |
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 GGP devicesGGP Test, Qualitative And Quantitative Factor Deficiency: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GGP
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GGP
153in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GGP
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GGP
3in 2025
MAUDE reports naming product code GGP, 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 | 3 | 153 | 2 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 2 | 4 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 2 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 3 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Factor deficient plasma, Factor - X is a human plasma immunodepleted of the specific factor and intended for use in the quantitative determination of the specific factor 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/K964459 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964459: Universal Reagent Factor X 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/K964459
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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