510(k) · Cleared
ClearedCryo Check Factor XI Deficient Plasma, Model FDP11-10 (1.Oml) and FDP11-15 (1.5ML)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Biologicals, Inc. · GJT Plasma, Coagulation Factor Deficient
Cleared on Jan 13, 1999 as substantially equivalent to K900411 (Sigma Chemical Co., 1990) after a 287-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Jan 13, 1999
- Review
- 287 days
- Class
- Class II
- Product code
- GJT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K900411 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK900411 Factor XI Deficient PlasmaSigma Chemical Co. · 1990
- This deviceK981173 Cryo Check Factor XI Deficient Plasma, Model FDP11-10 (1.Oml) and…Precision Biologicals, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900411 | Factor XI Deficient Plasma | Sigma Chemical Co. | 1990 | — |
| 0 (this device) | K981173 | Cryo Check Factor XI Deficient Plasma, Model FDP11-10 (1.Oml) and FDP11-15… | Precision Biologicals, Inc. | 1999 | — |
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 |
|---|---|---|---|
| * | K900411 | Factor XI Deficient PlasmaSummary page 2…mended for use as a substrate in clot-based Factor XI assays using the activated partial thromboplastin time (APTT). 5. Substantially Equivalent Device a) 510(k) number: K900411 b) c) Trade Name: Factor XI Deficient Plasma d) Manufacturer: Sigma e) Substantial Equivalence Comparison Cryov'Check™ Factor XI… | 1990 |
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?
Deficiencies in coagulation factors may have congenital or acquired etiologies and can compromise in vivo hemostasis. Factor XII (also known as Hageman factor) is a serine protease located in the “intrinsic coagulation pathway”. Patients with Factor XII deficiency generally do not have significant bleeding tendencies. Factor XII deficiency is commonly diagnosed in vitro through the use of the activated partial thromboplastin time (APTT). Cryov'Check™…
Read the full statement (107 words)
Deficiencies in coagulation factors may have congenital or acquired etiologies and can compromise in vivo hemostasis. Factor XII (also known as Hageman factor) is a serine protease located in the “intrinsic coagulation pathway”. Patients with Factor XII deficiency generally do not have significant bleeding tendencies. Factor XII deficiency is commonly diagnosed in vitro through the use of the activated partial thromboplastin time (APTT).
Cryov'Check™ Factor XII Deficient Plasma is human plasma deficient in the Factor XII coagulation protein while having all other coagulation factors greater than 50%. It is recommended for use as a substrate in clot-based Factor XII assays using the activated partial thromboplastin time (APTT).
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/K981173 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981173: Cryo Check Factor XI Deficient Plasma, Model FDP11-10 (1.Oml) and FDP11-15 (1.5ML).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981173
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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