510(k) · Cleared
ClearedHydragel-Mini Lipo Kit-PN 4093, Hydragel Lipo Kit-PN 4007, Hydragel Lipo Maxi Kit-PN 4207
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Morax · JHO Electrophoretic Separation, Lipoproteins
Cleared on Oct 7, 1998 after a 282-day review. The FDA summary names no predicate by number.
- Decided
- Oct 7, 1998
- Review
- 282 days
- Class
- Class I
- Product code
- JHO
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by 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 JHO? 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?
The FDA summary names no predicate by 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 JHO devicesJHO Electrophoretic Separation, Lipoproteins: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JHO
FDA has decided no JHO device since 2007.
Median 510(k) review, days · JHO
Too few JHO 510(k)s in any year since 2007 to give a median.
Recalls per year · JHO
No recall names JHO since 2007.
Adverse event reports per year · JHO
No MAUDE report names JHO since 2007.
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 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 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?
The HYDRAGEL-MINI LIPO, HYDRAGEL LIPO, HYDRAGEL LIPO MAXI, HYDRAGEL 7 LIPO, and HYDRAGEL 15/30 LIPO kits are designed for determination of lipoprotein profiles in human serum. All HYDRAGEL LIPO kits utilize the same composition of alkaline buffered HYDRAGEL LIPO agarose gels, same reagents and the same procedure. The only differences among the individual kits are the number of samples per gel and that some kits are for the manual and some for the…
Read the full statement (202 words)
The HYDRAGEL-MINI LIPO, HYDRAGEL LIPO, HYDRAGEL LIPO MAXI, HYDRAGEL 7 LIPO, and HYDRAGEL 15/30 LIPO kits are designed for determination of lipoprotein profiles in human serum.
All HYDRAGEL LIPO kits utilize the same composition of alkaline buffered HYDRAGEL LIPO agarose gels, same reagents and the same procedure. The only differences among the individual kits are the number of samples per gel and that some kits are for the manual and some for the automated format:
The HYDRAGEL-MINI LIPO, HYDRAGEL LIPO and HYDRAGEL LIPO MAXI kits are designed for use with a manual electrophoresis apparatus. These Kits are intended to run up to 5, 8 and 10 samples per gel, respectively.
The HYDRAGEL 7 LIPO and HYDRAGEL 15/30 LIPO kits are designed for use with the semi-automated Hydrasys electrophoresis apparatus. These kits are intended to run up to 7, 15 and 30 samples per gel, respectively.
The resulting electrophoregrams can be evaluated visually for pattern abnormalities or by densitometry to obtain approximate, relative quantification of individual zones. Fredrickson classification of lipoproteins aids in the interpretation of lipoprotein patterns. Indication of the qualitative (presence of abnormal or absence of normal fractions) or semi-quantitative (relative increase or decrease of fractions) abnormalities necessitates further lipoprotein analyses.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974854: Hydragel-Mini Lipo Kit-PN 4093, Hydragel Lipo Kit-PN 4007, Hydragel Lipo Maxi Kit-PN 4207.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974854
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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