510(k) · Cleared
ClearedCryocheck Prekallikrein Deficient Plalsma, Model FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Biologic · GJT Plasma, Coagulation Factor Deficient
Cleared on Mar 18, 1999 after a 49-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 18, 1999
- Review
- 49 days
- Class
- Class II
- Product code
- GJT
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
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. Prekallikrein or Fletcher factor, is a single chain polypeptide with a molecular weight of 85,000 and is necessary for normal coagulation of the “intrinsic coagulation pathway”. Prekallikrein deficiency is commonly diagnosed in vitro through the use of the activated partial thromboplastin time (APTT), an intrinsic pathway screening assay…
Read the full statement (109 words)
Deficiencies in coagulation factors may have congenital or acquired etiologies and can compromise in vivo hemostasis. Prekallikrein or Fletcher factor, is a single chain polypeptide with a molecular weight of 85,000 and is necessary for normal coagulation of the “intrinsic coagulation pathway”. Prekallikrein deficiency is commonly diagnosed in vitro through the use of the activated partial thromboplastin time (APTT), an intrinsic pathway screening assay and confirmed with a quantitative prekallikrein assay which is an APTT-based clotting assay.
Cryov'Check™ Prekallikrein Deficient Plasma is human plasma deficient in the prekallikrein coagulation protein. It is recommended for use as a substrate in clot-based prekallikrein assays using the activated partial thromboplastin time (APTT).
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990296 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990296: Cryocheck Prekallikrein Deficient Plalsma, Model FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990296
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026