510(k) · Cleared
ClearedLyphochek Hemostasis 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 27, 2004 as substantially equivalent to K020878 (Bio-Rad, 2002) after a 22-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Feb 27, 2004
- Review
- 22 days
- Class
- Class II
- Product code
- GGN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K941737 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941737 | Specialty Assayed Control-1 | Helena Laboratories | 1994 | — |
| −1 | K020878 | Lyphochek Hemostasis, Models 798, 799 | Bio-Rad | 2002 | — |
| 0 (this device) | K040275 | Lyphochek Hemostasis Control | Bio-Rad | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 |
|---|---|---|---|
| * | K020878 | Lyphochek Hemostasis, Models 798, 799Summary page 1…hich Substantial Equivalence is Claimed Lyphochek Hemostasis Control Bio-Rad Laboratories Irvine, California 510(k) Number: K020878 4.0 Description of Device Lyphochek® Hemostasis Control is prepared from human plasma with added purified… | 2002 |
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 10 years and passes through 2 companies; a new generation was cleared every 7.5 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K020878.
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?
For use as a quality control plasma to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
Analytes listed in the package insert:
Antithrombin III (AT III)
Activated Partial Thromboplastin Time (APTI)
D-dimer
Factor II
Factor V
Factor VIII
Factor VIII
Factor IX
Factor Xi
Factor XII
Fibrinogen
Plasminogen
Protein C (Functional)
Protein S (Functional)
Prothrombin Time (PT)
Thrombin Time (TT)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040275: Lyphochek Hemostasis Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040275
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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