510(k) · Cleared
ClearedLiquichek Blood Gas Plus CO-Oximeter Control (IL Synthesis Series) Levels 1,2, and 3, Models 667,668,669
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad · JJS Controls For Blood-Gases, (Assayed And Unassayed)
Cleared on Aug 15, 2002 as substantially equivalent to K003242 (Bio-Rad, 2000) after a 15-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Aug 15, 2002
- Review
- 15 days
- Class
- Class I
- Product code
- JJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003242 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK003242 Liquichek Blood Gas Plus CO-Oximeter Control (IL), Model 621,622,623Bio-Rad · 2000
- This deviceK022529 Liquichek Blood Gas Plus CO-Oximeter Control (IL Synthesis Series)…Bio-Rad · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003242 | Liquichek Blood Gas Plus CO-Oximeter Control (IL), Model 621,622,623 | Bio-Rad | 2000 | — |
| 0 (this device) | K022529 | Liquichek Blood Gas Plus CO-Oximeter Control (IL Synthesis Series) Levels 1,2… | Bio-Rad | 2002 | — |
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 JJS? 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 |
|---|---|---|---|
| * | K003242 | Liquichek Blood Gas Plus CO-Oximeter Control (IL), Model 621,622,623Summary page 2…l (IL Synthesis Series) claims substantial equivalence to the LiquichekTM Blood Gas Plus CO-Oximeter Control (IL) currently in commercial distribution (K003242). Bio Rad Bio Rad Characteristics… | 2000 |
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?
- Its one ancestor has no recall.
How does its category compare?
All JJS devicesJJS Controls For Blood-Gases, (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JJS
Too few JJS 510(k)s in any year since 2007 to give a median.
Recalls per year · JJS
No recall names JJS since 2007.
Adverse event reports per year · JJS
1in 2018
MAUDE reports naming product code JJS, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 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 | — | 0 | — |
What is it indicated for?
LiquichekTMBlood Gas Plus Co-Oximeter Control (IL Synthesis Series) is an assayed quality control intended for use in monitoring the precision of an individual laboratory’s measurement of pH, pCO2, pO2, electrolytes, glucose, total hemoglobin, and hemoglobin fractions by blood gas, ion selective electrode (ISE), biosensor and IL Synthesis Co-Oximetry instrumentation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022529 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022529: Liquichek Blood Gas Plus CO-Oximeter Control (IL Synthesis Series) Levels 1,2, and 3, Models 667,668,669.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022529
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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