510(k) · Cleared
Recalled · Class II · 2017QUALICHECK5+ Models S7730, S7740, S7750, S7760
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiometer America, Inc. · JJS Controls For Blood-Gases, (Assayed And Unassayed)
Cleared on Jan 28, 1998 as substantially equivalent to K961355 (Radiometer America, Inc., 1996) after a 13-day review. Its family tree reaches back 2 generations to 1996. 35 later devices descend from it. It has been recalled once.
- Decided
- Jan 28, 1998
- Review
- 13 days
- Class
- Class I
- Product code
- JJS
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K952725 (1996). 35 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK952725 MulticheckRadiometer America, Inc. · 1996
- 1 generation backK961355 MulticheckRadiometer America, Inc. · 1996
- This deviceK980135 QUALICHECK5+ Models S7730, S7740, S7750, S7760Radiometer America, Inc. · 1998
- Descendant · cites it directly · 31 of its ownK992859 ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · Recalled
- Descendant · 2 generations on · 29 of its ownK041874 ABL800 FlexRadiometer Medical Aps · 2004 · Recalled
- Descendant · 3 generations on · 18 of its ownK050869 Modification to ABL800 FlexRadiometer Medical Aps · 2005 · Recalled
- Descendant · cites it directly · 12 of its ownK092686 ABL90 Flex SeriesRadiometer Medical Aps · 2010 · Recalled
- Descendant · 2 generations on · 6 of its ownK120197 ABL90 FlexRadiometer Medical Aps · 2012 · Recalled
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K992859ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · cites it directly31descendants
- K041874ABL800 FlexRadiometer Medical Aps · 2004 · 2 generations on29descendants
- K050869Modification to ABL800 FlexRadiometer Medical Aps · 2005 · 3 generations on18descendants
- K092686ABL90 Flex SeriesRadiometer Medical Aps · 2010 · cites it directly12descendants
- K120197ABL90 FlexRadiometer Medical Aps · 2012 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K952725 | Multicheck | Radiometer America, Inc. | 1996 | — |
| −1 | K961355 | Multicheck | Radiometer America, Inc. | 1996 | — |
| 0 (this device) | K980135 | QUALICHECK5+ Models S7730, S7740, S7750, S7760 | Radiometer America, Inc. | 1998 | — |
| +1 | K992859 | ABL700 Series Analyzer with Autocheck Module | Radiometer America, Inc. | 2000 | 4 |
| +2 | K041874 | ABL800 Flex | Radiometer Medical Aps | 2004 | 22 |
| +3 | K050869 | Modification to ABL800 Flex | Radiometer Medical Aps | 2005 | 1 |
| +1 | K092686 | ABL90 Flex Series | Radiometer Medical Aps | 2010 | 10 |
| +2 | K120197 | ABL90 Flex | Radiometer Medical Aps | 2012 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K961355 | MulticheckSummary page 1…is technologically similar to Multicheck. SUBSTANTIAL EQUIVALENCE: QualicheckS+ is substantially equivalent in features and characteristics to the current Multicheck (K961355) marketed by Radiometer America Inc. The major difference is the addition of the chloride (cCL’) analyte. %, ot… | 1996 |
What descends from it? (35)
See all 356 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992859 | ABL700 Series Analyzer with Autocheck Module | 2000 | 31 |
| K092686 | ABL90 Flex Series | 2010 | 12 |
| K150226 | Hematocrit and Metabolite QUALICHECK | 2015 | 0 |
| K130415 | High Metabolite Qualicheck | 2013 | 0 |
| K130236 | Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck Level 3 | 2013 | 0 |
| K051928 | AUTOCHECK6+ | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 7, 2017 | Class II | Z-3237-2017 | Under Investigation by firm | Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect results for pCO2 and pO2. A defective QC ampoule will for: " pCO2 give a result close to or just outside of the low end of the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 1.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K992859 (Radiometer America, Inc., 2000) has gone furthest, with 31 descendants of its own.
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?
QualicheckS+ is a liquid, four ampoule quality control system, for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood gases, Co-oximetry, Electrolytes, Glucose and Lactate.
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/K980135 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980135: QUALICHECK5+ Models S7730, S7740, S7750, S7760.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980135
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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