510(k) · Cleared
ClearedLyphochek Coagulation Control Level 1, Lyphochek Coagulation Level 2, Lyphochek Coagulation Level 3, Models 781,782,783
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 Sep 18, 2001 as substantially equivalent to K990858 (Bio-Rad, 1999) after a 34-day review. Its family tree reaches back 3 generations to 1982. 1 later device descends from it.
- Decided
- Sep 18, 2001
- Review
- 34 days
- Class
- Class II
- Product code
- GGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K820450 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK820450 ThromboscreenPacific Hemostasis · 1982
- 2 generations backK964963 Lyphochek Coagulation ControlBio-Rad · 1997
- 1 generation backK990858 Lypochek Coagulation Control, Model Nos. 787, 788, 789Bio-Rad · 1999
- This deviceK012722 Lyphochek Coagulation Control Level 1, Lyphochek Coagulation Level…Bio-Rad · 2001
- Descendant · cites it directly · 0 of its ownK032611 Lyphochek Coagulation Control, Level 4, Model 743Bio-Rad · 2003
Most influential descendants
Showing 1 of 1 · See all- K032611Lyphochek Coagulation Control, Level 4, Model 743Bio-Rad · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K820450 | Thromboscreen | Pacific Hemostasis | 1982 | — |
| −2 | K964963 | Lyphochek Coagulation Control | Bio-Rad | 1997 | — |
| −1 | K990858 | Lypochek Coagulation Control, Model Nos. 787, 788, 789 | Bio-Rad | 1999 | — |
| 0 (this device) | K012722 | Lyphochek Coagulation Control Level 1, Lyphochek Coagulation Level 2… | Bio-Rad | 2001 | — |
| +1 | K032611 | Lyphochek Coagulation Control, Level 4, Model 743 | Bio-Rad | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K990858 | Lypochek Coagulation Control, Model Nos. 787, 788, 789Summary page 1…ation Number: 21 CFR 864.5425 Device to Which Substantial Equivalence is Claimed Lyphochek® Coagulation Control Bio-Rad Laboratories Irvine, California Docket Number: K990858 Description of Device Lyphochek® Coagulation Control is prepared from human plasma, with added purified biochemical and preserv… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032611 | Lyphochek Coagulation Control, Level 4, Model 743 | 2003 | 0 |
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 19 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K032611 (Bio-Rad, 2003) 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 | — |
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.
Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen and Antithrombin Ill (AT lil) are assayed on the MLA ELECTRA series. Thrombin Time (TT) is assayed on the Dade BBL Fibrometer (Becton Dickinson).
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/K012722 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012722: Lyphochek Coagulation Control Level 1, Lyphochek Coagulation Level 2, Lyphochek Coagulation Level 3, Models 781,782,783.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012722
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026