510(k) · Cleared
ClearedGonotec Calibration Solution 300 Mosmol/KG for Osmometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB · JIS Calibrator, Primary
Cleared on Oct 21, 2003 as substantially equivalent to K931834 (King Diagnostics, Inc., 1993) after a 57-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Oct 21, 2003
- Review
- 57 days
- Class
- Class II
- Product code
- JIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931834 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK931834 King Sodium/Potassium Standard ModifiedKing Diagnostics, Inc. · 1993
- This deviceK032608 Gonotec Calibration Solution 300 Mosmol/KG for OsmometerGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931834 | King Sodium/Potassium Standard Modified | King Diagnostics, Inc. | 1993 | — |
| 0 (this device) | K032608 | Gonotec Calibration Solution 300 Mosmol/KG for Osmometer | Gonotec Gesellschaft Fuer Mess-Und Regeltechnik MB | 2003 | — |
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 JIS? 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 |
|---|---|---|---|
| * | K931834 | King Sodium/Potassium Standard ModifiedSummary page 1…alence. PREDICATE DEVlCE: 51O(k)- Regulation Product decision date Applicant name Device name number number Code K931834 862.1150 JIS 08-25-1993 King Diagnostics, Sodium/Potassium… | 1993 |
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?
- Its one ancestor has no recall.
How does its category compare?
All JIS devicesJIS Calibrator, Primary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIS
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · JIS
Too few JIS 510(k)s in any year since 2007 to give a median.
Recalls per year · JIS
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIS
1in 2024
MAUDE reports naming product code JIS, 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 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 2 | 5 |
| 2012 | 1 | — | 1 | 5 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 1 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 1 | 7 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 1 | 11 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
IVD DEVICE CALIBRATION IS MOST COMMONLY PERFORMED USING CALIBRATORS (REFERENCE MATERIALS) SPECIFICALLY INTENDED TO BE USED AS A STANDARD CURVE OR CUT-OFF POINT FOR AN ASSAY. A CALIBRATOR HAS AN ASSIGNED VALUE THAT IS ESTABLISHED BY THE MANUFACTURER BY A REFERENCE METHOD. CALIBRATORS EXIST IN A VARIETY OF MATRICES SUCH AS SIMULATED AQUEOUS, SERUM, PLASMA OR OTHER TYPES OF SPECIMENS. PRIMARY REFERENCE CALIBRATORS ARE HIGHLY PURIFIED CHEMICALS THAT CAN BE…
Read the full statement (189 words)
IVD DEVICE CALIBRATION IS MOST COMMONLY PERFORMED USING CALIBRATORS (REFERENCE MATERIALS) SPECIFICALLY INTENDED TO BE USED AS A STANDARD CURVE OR CUT-OFF POINT FOR AN ASSAY.
A CALIBRATOR HAS AN ASSIGNED VALUE THAT IS ESTABLISHED BY THE MANUFACTURER BY A REFERENCE METHOD. CALIBRATORS EXIST IN A VARIETY OF MATRICES SUCH AS SIMULATED AQUEOUS, SERUM, PLASMA OR OTHER TYPES OF SPECIMENS.
PRIMARY REFERENCE CALIBRATORS ARE HIGHLY PURIFIED CHEMICALS THAT CAN BE DIRECTLY WEIGHED OR MEASURED TO PRODUCE A SOLUTION OF KNOWN CONCENTRATION. ALTERNATIVELY, THEY MAY BE MORE COMPLEX BIOLOGICAL MATERIALS HAVING RECEIVED A VALUE ASSIGNMENT USING REFERENCE (STANDARD) METHODOLOGY. THEY ARE SUPPLIED WITH A CERTIFICATE OF ANALYSIS FOR EACH LOT (FOR EXAMPLE, STANDARD REFERENCE MATERIALS (SRMS) FROM THE U.S. NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY (NIST)).
THE PRIMARY CALIBRATOR “CALIBRATION SOLUTION FOR OSMOMAT 010 / 030 / auto” IS USED TO CALIBRATE THE OSMOMETERS “OSMOMAT 030” AND “OSMOMAT AUTO”, WHICH BOTH ARE FREEZING-POINT OSMOMETERS FOR USE IN CLINICAL CHEMISTRY. THE OSMOLALITY OF THE CALIBRATOR IS EQUAL TO THE OSMOLALITY OF BODY-FLUIDS (ISOTONIC SOLUTION), PROVIDING THAT THE OSMOMETER WILL BE CALIBRATED CORRECTLY FOR THE FLUIDS TO BE MEASURED FOR MEDICAL PURPOSES.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032608 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032608: Gonotec Calibration Solution 300 Mosmol/KG for Osmometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032608
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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