510(k) · Cleared
ClearedLyphochek Whole Blood Control (Human) Levels 1,2,3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Jan 18, 1990 after a 104-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Jan 18, 1990
- Review
- 104 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK895905 Lyphochek Whole Blood Control (Human) Levels 1,2,3Bio-Rad · 1990
- Descendant · cites it directly · 9 of its ownK980871 Lyphochek Whole Blood ControlBio-Rad · 1998
- Descendant · 2 generations on · 6 of its ownK022041 Lyphochek Whole Blood Control, Models 561, 562, 563Bio-Rad Laboratories, Inc. · 2002
- Descendant · 3 generations on · 2 of its ownK072721 Lyphochek Whole Blood Immunosuppressant Control , Abbott…Bio-Rad, Diagnostics Grp. · 2007
- Descendant · 2 generations on · 1 of its ownK984477 Lyphochek Whole Blood Metals Control Levels 1,2,3, Models 527, 528…Bio-Rad · 1999
- Descendant · 4 generations on · 0 of its ownK132174 Multichem WBTTechno-Path Manufacturing, Ltd. · 2013
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K980871Lyphochek Whole Blood ControlBio-Rad · 1998 · cites it directly9descendants
- K022041Lyphochek Whole Blood Control, Models 561, 562, 563Bio-Rad Laboratories, Inc. · 2002 · 2 generations on6descendants
- K072721Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCCBio-Rad, Diagnostics Grp. · 2007 · 3 generations on2descendants
- K984477Lyphochek Whole Blood Metals Control Levels 1,2,3, Models 527, 528, 529Bio-Rad · 1999 · 2 generations on1descendant
- K132174Multichem WBTTechno-Path Manufacturing, Ltd. · 2013 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K895905 | Lyphochek Whole Blood Control (Human) Levels 1,2,3 | Bio-Rad | 1990 | — |
| +1 | K980871 | Lyphochek Whole Blood Control | Bio-Rad | 1998 | — |
| +2 | K022041 | Lyphochek Whole Blood Control, Models 561, 562, 563 | Bio-Rad Laboratories, Inc. | 2002 | — |
| +3 | K072721 | Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCC | Bio-Rad, Diagnostics Grp. | 2007 | — |
| +2 | K984477 | Lyphochek Whole Blood Metals Control Levels 1,2,3, Models 527, 528, 529 | Bio-Rad | 1999 | — |
| +4 | K132174 | Multichem WBT | Techno-Path Manufacturing, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 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 JJY? 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980871 | Lyphochek Whole Blood Control | 1998 | 9 |
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, K980871 (Bio-Rad, 1998) has gone furthest, with 9 descendants of its own.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K895905 · printed Nov 4, 2026
Cite this page
510(k) Report. “K895905: Lyphochek Whole Blood Control (Human) Levels 1,2,3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K895905
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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