510(k) · Cleared
ClearedLyphochek Coagulation Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · GGN Plasma, Coagulation Control
Cleared on Feb 20, 1997 as substantially equivalent to K820450 (Pacific Hemostasis, 1982) after a 71-day review. Its family tree reaches back 1 generation to 1982. 3 later devices descend from it.
- Decided
- Feb 20, 1997
- Review
- 71 days
- Class
- Class II
- Product code
- GGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K820450 (1982). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK820450 ThromboscreenPacific Hemostasis · 1982
- This deviceK964963 Lyphochek Coagulation ControlBio-Rad · 1997
- Descendant · cites it directly · 2 of its ownK990858 Lypochek Coagulation Control, Model Nos. 787, 788, 789Bio-Rad · 1999
- Descendant · 2 generations on · 1 of its ownK012722 Lyphochek Coagulation Control Level 1, Lyphochek Coagulation Level…Bio-Rad · 2001
- Descendant · 3 generations on · 0 of its ownK032611 Lyphochek Coagulation Control, Level 4, Model 743Bio-Rad · 2003
Most influential descendants
Showing 3 of 3 · See all- K990858Lypochek Coagulation Control, Model Nos. 787, 788, 789Bio-Rad · 1999 · cites it directly2descendants
- K012722Lyphochek Coagulation Control Level 1, Lyphochek Coagulation Level 2, Lyphochek…Bio-Rad · 2001 · 2 generations on1descendant
- K032611Lyphochek Coagulation Control, Level 4, Model 743Bio-Rad · 2003 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K820450 | Thromboscreen | Pacific Hemostasis | 1982 | — |
| 0 (this device) | K964963 | Lyphochek Coagulation Control | Bio-Rad | 1997 | — |
| +1 | K990858 | Lypochek Coagulation Control, Model Nos. 787, 788, 789 | Bio-Rad | 1999 | — |
| +2 | K012722 | Lyphochek Coagulation Control Level 1, Lyphochek Coagulation Level 2… | Bio-Rad | 2001 | — |
| +3 | K032611 | Lyphochek Coagulation Control, Level 4, Model 743 | Bio-Rad | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 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 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? (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 |
|---|---|---|---|
| * | K820450 | ThromboscreenSummary page 1…lass li, 81GGN CFR 864.5425: Plasma Coagulation Control Devices to Which Substantial Equivalence is Claimed ThromboScreen Coagulation Control Plasma Pacific Hemostasis K820450 Statement of Intended Use Lyphochek Coagulation Control is intended for use as a quality control plasma to monitor the precision… | 1982 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990858 | Lypochek Coagulation Control, Model Nos. 787, 788, 789 | 1999 | 2 |
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.
- Of its descendants, K990858 (Bio-Rad, 1999) has gone furthest, with 2 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 | — |
What is it indicated for?
Lyphochek Coagulation Control is intended for use as a quality control plasma to monitor the precision of citrated coagulation systems.
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/K964963 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964963: Lyphochek Coagulation Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964963
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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