510(k) · Cleared
ClearedPrestige Models 24I and 400 and MGC Model 240
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tokyo Boeki Medical System, Ltd. · JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Cleared on Feb 15, 2005 as substantially equivalent to K851172 (Roche Diagnostic Systems, Inc., 1985) after a 308-day review. Its family tree reaches back 1 generation to 1985. 2 later devices descend from it.
- Decided
- Feb 15, 2005
- Review
- 308 days
- Class
- Class I
- Product code
- JJE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K851172 (1985). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK851172 Cobas MiraRoche Diagnostic Systems, Inc. · 1985
- This deviceK040958 Prestige Models 24I and 400 and MGC Model 240Tokyo Boeki Medical System, Ltd. · 2005
- Descendant · cites it directly · 0 of its ownK120591 Diamond Tokyo Boeki Ise Module Calibrator 1,2,1-2Diamond Diagnostics, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK110520 Biolis 12ITokyo Boeki Medisys, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K851172 | Cobas Mira | Roche Diagnostic Systems, Inc. | 1985 | — |
| 0 (this device) | K040958 | Prestige Models 24I and 400 and MGC Model 240 | Tokyo Boeki Medical System, Ltd. | 2005 | — |
| +1 | K120591 | Diamond Tokyo Boeki Ise Module Calibrator 1,2,1-2 | Diamond Diagnostics, Inc. | 2012 | — |
| +1 | K110520 | Biolis 12I | Tokyo Boeki Medisys, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 JJE? 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 |
|---|---|---|---|
| * | K851172 | Cobas MiraSummary page 2…assium and chloride in samples, using indirect potentiometry. Substantial Equivalence: Substantial equivalence has been demonstrated between the Roche Cobas Mira Plus (K851172) and the Prestige 24i. Both analyzers are used to analyze for electrolytes. Both analyzers are calibrated with known conce… | 1985 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All JJE devicesJJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJE
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · JJE
224in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJE
6in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJE
4,400in 2025
MAUDE reports naming product code JJE, 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 | — | 20 | 2,181 |
| 2008 | 1 | — | 20 | 2,159 |
| 2009 | 0 | — | 14 | 3,440 |
| 2010 | 0 | — | 32 | 3,273 |
| 2011 | 2 | — | 25 | 11,606 |
| 2012 | 1 | — | 16 | 3,707 |
| 2013 | 1 | — | 21 | 2,489 |
| 2014 | 3 | 224 | 14 | 2,841 |
| 2015 | 0 | — | 15 | 2,793 |
| 2016 | 0 | — | 9 | 2,580 |
| 2017 | 0 | — | 18 | 1,869 |
| 2018 | 0 | — | 17 | 4,590 |
| 2019 | 1 | — | 7 | 3,948 |
| 2020 | 0 | — | 7 | 3,986 |
| 2021 | 0 | — | 6 | 3,920 |
| 2022 | 0 | — | 0 | 3,998 |
| 2023 | 0 | — | 12 | 3,783 |
| 2024 | 0 | — | 6 | 4,221 |
| 2025 | 0 | — | 6 | 4,400 |
| 2026 | 0 | — | 5 | — |
What is it indicated for?
This device with an optional Ion Selective Electrode (ISE) module is a clinical chemistry analyzer intended to be used for the measurement of sodium, potassium and chloride in serum to monitor electrolyte balance.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040958 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040958: Prestige Models 24I and 400 and MGC Model 240.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040958
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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