510(k) · Cleared
ClearedMulticheck
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 Jun 14, 1996 as substantially equivalent to K952725 (Radiometer America, Inc., 1996) after a 67-day review. Its family tree reaches back 1 generation to 1996. 36 later devices descend from it.
- Decided
- Jun 14, 1996
- Review
- 67 days
- Class
- Class I
- Product code
- JJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952725 (1996). 36 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK952725 MulticheckRadiometer America, Inc. · 1996
- This deviceK961355 MulticheckRadiometer America, Inc. · 1996
- Descendant · cites it directly · 35 of its ownK980135 QUALICHECK5+ Models S7730, S7740, S7750, S7760Radiometer America, Inc. · 1998 · Recalled
- Descendant · 2 generations on · 31 of its ownK992859 ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · Recalled
- Descendant · 3 generations on · 29 of its ownK041874 ABL800 FlexRadiometer Medical Aps · 2004 · Recalled
- Descendant · 4 generations on · 18 of its ownK050869 Modification to ABL800 FlexRadiometer Medical Aps · 2005 · Recalled
- Descendant · 2 generations on · 12 of its ownK092686 ABL90 Flex SeriesRadiometer Medical Aps · 2010 · Recalled
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K980135QUALICHECK5+ Models S7730, S7740, S7750, S7760Radiometer America, Inc. · 1998 · cites it directly35descendants
- K992859ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · 2 generations on31descendants
- K041874ABL800 FlexRadiometer Medical Aps · 2004 · 3 generations on29descendants
- K050869Modification to ABL800 FlexRadiometer Medical Aps · 2005 · 4 generations on18descendants
- K092686ABL90 Flex SeriesRadiometer Medical Aps · 2010 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952725 | Multicheck | Radiometer America, Inc. | 1996 | — |
| 0 (this device) | K961355 | Multicheck | Radiometer America, Inc. | 1996 | — |
| +1 | K980135 | QUALICHECK5+ Models S7730, S7740, S7750, S7760 | Radiometer America, Inc. | 1998 | 1 |
| +2 | K992859 | ABL700 Series Analyzer with Autocheck Module | Radiometer America, Inc. | 2000 | 4 |
| +3 | K041874 | ABL800 Flex | Radiometer Medical Aps | 2004 | 22 |
| +4 | K050869 | Modification to ABL800 Flex | Radiometer Medical Aps | 2005 | 1 |
| +2 | K092686 | ABL90 Flex Series | Radiometer Medical Aps | 2010 | 10 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K952725 | MulticheckSummary page 1…Multicheck™ with glucose. SUBSTANTIAL EQUIVALENCE: Multicheck™ with metabolite is substantially equivalent in features and characteristics to the current Multicheck (K952725) marketed by RadiometerAmerica Inc. The only difference is the addition of the lactate analyte. | 1996 |
What descends from it? (36)
See all 361 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980135 | QUALICHECK5+ Models S7730, S7740, S7750, S7760 | 1998 | 35 |
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.
- Of its descendants, K980135 (Radiometer America, Inc., 1998) has gone furthest, with 35 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?
Multicheck™ with metabolite is intended for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood Gases, Oximetry, Electrolytes, and 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/K961355 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961355: Multicheck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961355
Report an extraction error
Are you the manufacturer?
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