510(k) · Cleared
ClearedCRYOcheck Factor VIII Deficient Plasma with VWF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Biologic, Inc. · GJT Plasma, Coagulation Factor Deficient
Cleared on Sep 13, 2023 as substantially equivalent to K110237 (Instrumentation Laboratory CO, 2011) after a 359-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Sep 13, 2023
- Review
- 359 days
- Class
- Class II
- Product code
- GJT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K893525 (1989). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK893525 Factor Viii Deficient PlasmaMedical Diagnostic Technologies, Inc. · 1989
- 2 generations backK034007 Hemosil Factor Viii Deficient PlasmaInstrumentation Laboratory CO · 2004
- 1 generation backK110237 Hemosil Factor Viii Deficient PlasmaInstrumentation Laboratory CO · 2011
- This deviceK222831 CRYOcheck Factor VIII Deficient Plasma with VWFPrecision Biologic, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K893525 | Factor Viii Deficient Plasma | Medical Diagnostic Technologies, Inc. | 1989 | — |
| −2 | K034007 | Hemosil Factor Viii Deficient Plasma | Instrumentation Laboratory CO | 2004 | — |
| −1 | K110237 | Hemosil Factor Viii Deficient Plasma | Instrumentation Laboratory CO | 2011 | — |
| 0 (this device) | K222831 | CRYOcheck Factor VIII Deficient Plasma with VWF | Precision Biologic, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K110237 | Hemosil Factor Viii Deficient PlasmaSummary page 4…Deficient; 21 CFR 864.7290 Classification Panel Hematology Predicate Device HemosIL Factor VIII Deficient Plasma (K110237) Indication for Use/ CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical Intended Use laboratory… | 2011 |
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?
- The line of descent spans 34 years and passes through 3 companies; a new generation was cleared every 12.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
How does its category compare?
All GJT devicesGJT Plasma, Coagulation Factor Deficient: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
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?
CRYOcheck Factor VIII Deficient Plasma with VWF is for clinical laboratory use as a deficient substrate in the quantitative determination of Factor VIII activity in 3.2% citrated human plasma based on the activated partial thromboplastin time (APTT) assay. It is intended to be used in identifying factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222831 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222831: CRYOcheck Factor VIII Deficient Plasma with VWF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222831
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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