510(k) · Cleared
ClearedTitan Gel Lipoprotein Electrophoresis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Helena Laboratories · JHO Electrophoretic Separation, Lipoproteins
Cleared on Mar 15, 1984 after a 154-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Mar 15, 1984
- Review
- 154 days
- Class
- Class I
- Product code
- JHO
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK833611 Titan Gel Lipoprotein ElectrophoresisHelena Laboratories · 1984
- Descendant · cites it directly · 0 of its ownK991083 RLP Cholesterol Immunoseparation AssayOtsuka Pharmaceutical Co., Ltd. · 1999
- Descendant · cites it directly · 0 of its ownK960785 LFS Lipogel Assay KitZaxis, Inc. · 1996
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 |
|---|---|---|---|---|---|
| 0 (this device) | K833611 | Titan Gel Lipoprotein Electrophoresis | Helena Laboratories | 1984 | — |
| +1 | K991083 | RLP Cholesterol Immunoseparation Assay | Otsuka Pharmaceutical Co., Ltd. | 1999 | — |
| +1 | K960785 | LFS Lipogel Assay Kit | Zaxis, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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?
- Of its descendants, K991083 (Otsuka Pharmaceutical Co., Ltd., 1999) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K833611 · printed Nov 6, 2026
Cite this page
510(k) Report. “K833611: Titan Gel Lipoprotein Electrophoresis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K833611
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026