510(k) · Cleared
ClearedCryo Check Normal Human Reference Plasma
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Biologicals, Inc. · GGN Plasma, Coagulation Control
Cleared on Oct 30, 1995 after a 144-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.
- Decided
- Oct 30, 1995
- Review
- 144 days
- Class
- Class II
- Product code
- GGN
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK952622 Cryo Check Normal Human Reference PlasmaPrecision Biologicals, Inc. · 1995
- Descendant · cites it directly · 0 of its ownK091284 Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and…Affinity Biologicals, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK022046 Vital Scientific Coagulation Control,Coagulation Control Level…Vital Scientific N.V. · 2002
Most influential descendants
Showing 2 of 2 · See all- K091284Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal Control PlasmaAffinity Biologicals, Inc. · 2009 · cites it directly0descendants
- K022046Vital Scientific Coagulation Control,Coagulation Control Level 1,2,3,Quikcoag…Vital Scientific N.V. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K952622 | Cryo Check Normal Human Reference Plasma | Precision Biologicals, Inc. | 1995 | — |
| +1 | K091284 | Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal… | Affinity Biologicals, Inc. | 2009 | — |
| +1 | K022046 | Vital Scientific Coagulation Control,Coagulation Control Level 1,2,3,Quikcoag… | Vital Scientific N.V. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2009 | 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 GGN? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K091284 (Affinity Biologicals, Inc., 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GGN devicesGGN Plasma, Coagulation Control: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GGN
4in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · GGN
96in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GGN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GGN
4in 2018
MAUDE reports naming product code GGN, 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 | 3 | 47 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 37 |
| 2010 | 3 | 23 | 4 | 17 |
| 2011 | 2 | — | 1 | 30 |
| 2012 | 1 | — | 0 | 10 |
| 2013 | 3 | 441 | 3 | 9 |
| 2014 | 2 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 2 | — | 0 | 9 |
| 2017 | 4 | 96 | 0 | 11 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 2 | — |
https://510kreport.com/device/K952622 · printed Nov 4, 2026
Cite this page
510(k) Report. “K952622: Cryo Check Normal Human Reference Plasma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952622
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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