510(k) · Cleared
ClearedHigh Metabolite Qualicheck
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 26, 2013 as substantially equivalent to K980135 (Radiometer America, Inc., 1998) after a 35-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Mar 26, 2013
- Review
- 35 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 deviceK130415 High Metabolite QualicheckRadiometer 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) | K130415 | High Metabolite 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 1…CHECK is substantially equivalent in Intended Use, fundamental scientific technology, features, and characteristics to the predicate: 510(k) Number/Device Manufacturer: K980135 QUALICHECK5+, Radiometer Medical ApS Tra ditional 510(k): High Metabolite QUALICHECK RADIOMETE… | 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?
This High Metabolite QUALICHECK solution is an assayed quality control system for
evaluating the accuracy and precision of all parameters listed on the insert specifying the
control ranges.
Analytes are: pO2, ctHb, cGlucose, cLactate
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130415 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130415: High Metabolite Qualicheck.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130415
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