510(k) · Cleared
ClearedSpife Lipporotein-12, Model 3344
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 Aug 15, 2002 after a 28-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 15, 2002
- Review
- 28 days
- Class
- Class I
- Product code
- JHO
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 SPIFE Lipoprotein-12 System is intended for the separation and quantitation of serum or plasma lipoproteins used in the diagnosis and treatment of lipid disorders, atherosclerosis, and various liver and renal diseases.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K022333 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022333: Spife Lipporotein-12, Model 3344.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022333
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026