510(k) · Cleared
ClearedFactor XI Deficient Plasma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sigma Chemical Co. · GJT Plasma, Coagulation Factor Deficient
Cleared on Mar 6, 1990 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.
- Decided
- Mar 6, 1990
- Review
- 36 days
- Class
- Class II
- Product code
- GJT
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK900411 Factor XI Deficient PlasmaSigma Chemical Co. · 1990
- Descendant · cites it directly · 0 of its ownK981173 Cryo Check Factor XI Deficient Plasma, Model FDP11-10 (1.Oml) and…Precision Biologicals, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K981173Cryo Check Factor XI Deficient Plasma, Model FDP11-10 (1.Oml) and FDP11-15 (1.5ML)Precision Biologicals, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K900411 | Factor XI Deficient Plasma | Sigma Chemical Co. | 1990 | — |
| +1 | K981173 | Cryo Check Factor XI Deficient Plasma, Model FDP11-10 (1.Oml) and FDP11-15… | Precision Biologicals, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981173 | Cryo Check Factor XI Deficient Plasma, Model FDP11-10 (1.Oml) and FDP11-15 (1.5ML) | 1999 | 0 |
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, K981173 (Precision Biologicals, Inc., 1999) has gone furthest, with 0 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/K900411 · printed Nov 4, 2026
Cite this page
510(k) Report. “K900411: Factor XI 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/K900411
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026