510(k) · Cleared
ClearedCryo Check Factor Xii Deficient Plasma Model FDP12-10 (1.0ML) and FDP12-15 (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 K900412 (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 K900412 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK900412 Factor Xii Deficient PlasmaSigma Chemical Co. · 1990
- This deviceK981174 Cryo Check Factor Xii Deficient Plasma Model FDP12-10 (1.0ML) and…Precision Biologicals, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900412 | Factor Xii Deficient Plasma | Sigma Chemical Co. | 1990 | — |
| 0 (this device) | K981174 | Cryo Check Factor Xii Deficient Plasma Model FDP12-10 (1.0ML) and FDP12-15… | 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 |
|---|---|---|---|
| * | K900412 | Factor Xii Deficient PlasmaSummary page 2…s a substrate in clot-based Factor XII assays using the activated partial thromboplastin time (APTT) assay. Substantially Equivalent Device a) b) c) d) 510(k) number: K900412 Trade Name: Factor XII Deficient Plasma Manufacturer: Sigma Substantial Equivalence Comparison Cryov'Check™ Factor XII Defici… | 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?
Cryov'Check™ Factor XII Deficient Plasma is recommended for use as a substrate in clot-based Factor XII assays using the activated partial thromboplastin time (APTT) 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/K981174 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981174: Cryo Check Factor Xii Deficient Plasma Model FDP12-10 (1.0ML) and FDP12-15 (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/K981174
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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