510(k) · Cleared
ClearedRange + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck Level 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiometer Medical Aps · JJS Controls For Blood-Gases, (Assayed And Unassayed)
Cleared on Mar 15, 2013 as substantially equivalent to K980135 (Radiometer America, Inc., 1998) after a 44-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Mar 15, 2013
- Review
- 44 days
- Class
- Class I
- Product code
- JJS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K952725 (1996). No later device cites it as a predicate yet.
- Root · 3 generations backK952725 MulticheckRadiometer America, Inc. · 1996
- 2 generations backK961355 MulticheckRadiometer America, Inc. · 1996
- 1 generation backK980135 QUALICHECK5+ Models S7730, S7740, S7750, S7760Radiometer America, Inc. · 1998 · Recalled
- This deviceK130236 Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range +…Radiometer Medical Aps · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952725 | Multicheck | Radiometer America, Inc. | 1996 | — |
| −2 | K961355 | Multicheck | Radiometer America, Inc. | 1996 | — |
| −1 | K980135 | QUALICHECK5+ Models S7730, S7740, S7750, S7760 | Radiometer America, Inc. | 1998 | 1 |
| 0 (this device) | K130236 | Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck… | Radiometer Medical Aps | 2013 | — |
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 |
|---|---|---|---|
| * | K980135 | QUALICHECK5+ Models S7730, S7740, S7750, S7760Summary page 2…l 1-3 is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate:. 510(k) Number/Device Manufacture: k980135 QUALICHECKS±, Radiometer Medical ApS Similarities 'Issue.… | 1998 |
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?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 5 other devices also cite its predicate K980135.
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. 2013, this device’s year, is highlighted.
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?
For In Vitro Diagnostic Use. This Range± QUALICHECK solution i an assayed quality control system for evaluating the accuracy and precision of all parameters listed on the insert specifying the control ranges.
Analytes are:
pH, PCO 2, PO2, ctHb, SO2 , FO2Hb, FCOHb, FMetI-b, FHbF-, cKt, cNa', cCa2 1,cCF-, cGlu, cLac, ctBil
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130236 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130236: Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck Level 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130236
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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