510(k) · Cleared
ClearedAUTOCHECK6+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiometer Medical Aps · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Oct 12, 2005 as substantially equivalent to K980135 (Radiometer America, Inc., 1998) and 1 other predicate after an 86-day review. Its family tree reaches back 4 generations to 1986.
- Decided
- Oct 12, 2005
- Review
- 86 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K861087 (1986). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK861087 Avl Model 983 Electrolyte AnalyzerAvl Scientific Corp. · 1986
- 3 generations backK961458 Avl 9180 Electrolyte AnalyzerAvl Scientific Corp. · 1996 · Recalled
- 2 generations backK972673 Avl 9181 Electrolyte AnalyzerAvl Scientific Corp. · 1997 · Recalled
- 1 generation backK992859 ABL700 Series Analyzer with Autocheck ModuleRadiometer America, Inc. · 2000 · Recalled
- This deviceK051928 AUTOCHECK6+Radiometer Medical Aps · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K861087 | Avl Model 983 Electrolyte Analyzer | Avl Scientific Corp. | 1986 | — |
| −3 | K961458 | Avl 9180 Electrolyte Analyzer | Avl Scientific Corp. | 1996 | 1 |
| −2 | K972673 | Avl 9181 Electrolyte Analyzer | Avl Scientific Corp. | 1997 | 7 |
| −1 | K992859 | ABL700 Series Analyzer with Autocheck Module | Radiometer America, Inc. | 2000 | 4 |
| 0 (this device) | K051928 | AUTOCHECK6+ | Radiometer Medical Aps | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 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 JJY? 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? (2)
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…lassification Name: Quality Control Material (Assayed and Unassayed) (21 CFR Section 862.1660) Predicate Devices QUALICHECK5+ (K9801 35) and AutoCheck5+ (part of K992859 - ABL7000 with AutoCheck Module), Device Description AutoCheck6+ is a four level quality cont… | 1998 |
| * | K992859 | ABL700 Series Analyzer with Autocheck ModuleSummary page 1…ty Control Material (Assayed and Unassayed) (21 CFR Section 862.1660) Predicate Devices QUALICHECK5+ (K9801 35) and AutoCheck5+ (part of K992859 - ABL7000 with AutoCheck Module), Device Description AutoCheck6+ is a four level quality control system consisting of part numb… | 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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- 7 of the 14 ancestors have a recall of any class.
- 5 other devices also cite its predicate K980135.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The AutoCheck6+ is a liquid four ampoule quality control system for checking the precision and accuracy of Radiometer Medical ApS analyzers for pH/Blood Gases, Co-oximetry, Electrolytes, Bilirubin, Glucose, Lactate, and Creatinine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051928 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051928: AUTOCHECK6+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051928
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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