510(k) · Cleared
ClearedCalibrating Material, Buffers, Standard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mission Diagnostics · JIT Calibrator, Secondary
Cleared on Jul 22, 2002 after a 31-day review. The FDA summary names its predicate without a number.
- Decided
- Jul 22, 2002
- Review
- 31 days
- Class
- Class II
- Product code
- JIT
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 JIT? 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? (11)
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 |
|---|---|---|---|
| * | — | Dade Dimension® ISE Standard C D100 Named without a submission number | |
| * | — | Dade Dimension® ISE Standard A D102 Named without a submission number | |
| * | — | Dade Dimension® ISE Standard B D103A Named without a submission number | |
| * | — | Dade Dimension® ISE Standard C D200 Named without a submission number | |
| * | — | Dade Dimension® ISE Standard A D202 Named without a submission number | |
| * | — | Roche Standard 1 for Cobas® ISE Module 46997 Named without a submission number | |
| * | — | Roche Standard 2 for Cobas® ISE Module 46998 Named without a submission number | |
| * | — | IL Test™ 7.384 pH Reference Buffer Named without a submission number | |
| * | — | IL Test™ 6.840 pH Reference Buffer Named without a submission number | |
| * | — | IL Test™ Cal 1 Named without a submission number | |
| * | — | IL Test™ Cal 2 Named without a submission number |
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.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, 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 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The products encompassed by this request are intended for in-vitro diagnostics use and are intended for use in calibrating the electrodes and flushing the sample flow path of the equivalent OEM Analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022027 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022027: Calibrating Material, Buffers, Standard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022027
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026