510(k) · Cleared
ClearedLyphochek Hemostasis, Models 798, 799
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · GGC Control, Plasma, Abnormal
Cleared on Apr 15, 2002 as substantially equivalent to K941737 (Helena Laboratories, 1994) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.
- Decided
- Apr 15, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- GGC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K941737 (1994). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK941737 Specialty Assayed Control-1Helena Laboratories · 1994
- This deviceK020878 Lyphochek Hemostasis, Models 798, 799Bio-Rad · 2002
- Descendant · cites it directly · 0 of its ownK043451 Biophen Normal and Abnormal Control Plasma; Biophen Plasma CalibratorHyphen Biomed · 2005
- Descendant · cites it directly · 0 of its ownK040275 Lyphochek Hemostasis ControlBio-Rad · 2004
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941737 | Specialty Assayed Control-1 | Helena Laboratories | 1994 | — |
| 0 (this device) | K020878 | Lyphochek Hemostasis, Models 798, 799 | Bio-Rad | 2002 | — |
| +1 | K043451 | Biophen Normal and Abnormal Control Plasma; Biophen Plasma Calibrator | Hyphen Biomed | 2005 | — |
| +1 | K040275 | Lyphochek Hemostasis Control | Bio-Rad | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 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 GGC? 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? (2)
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 |
|---|---|---|---|
| * | K941737 | Specialty Assayed Control-1Summary page 1…ion Number: 21 CFR 864.5425 Device to Which Substantial Equivalence is Claimed Coagulation S.A.C Assayed Control 1 Helena Laboratories Beaumont, Texas ‘Docket Number: K941737 Coagulation S.A.C Assayed Control 2 Helena Laboratories Beaumont, Texas Docket Number: K941872 Description of Device Lyphochek… | 1994 |
| * | K941872 | Specialty Assayed Control-2 Cat. NO. 5302Summary page 1…C Assayed Control 1 Helena Laboratories Beaumont, Texas ‘Docket Number: K941737 Coagulation S.A.C Assayed Control 2 Helena Laboratories Beaumont, Texas Docket Number: K941872 Description of Device Lyphochek® Hemostasis Control is prepared from human plasma with added purified biochemicals and preservat… | 1994 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K043451 (Hyphen Biomed, 2005) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GGC devicesGGC Control, Plasma, Abnormal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GGC
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · GGC
Too few GGC 510(k)s in any year since 2007 to give a median.
Recalls per year · GGC
No recall names GGC since 2007.
Adverse event reports per year · GGC
1in 2021
MAUDE reports naming product code GGC, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Lyphochek® Hemostasis Control is intended for use as a quality control
plasma to monitor the precision of laboratory testing procedures for the
analytes listed in the package insert.
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/K020878 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020878: Lyphochek Hemostasis, Models 798, 799.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020878
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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