510(k) · Cleared

Cleared

Rep Direct-Sep Cholesterol-15 Kit; Cholesterol-8 Kit; Cholesterol-4 Kit

K935162510(k) TraditionalCleared Nov 10, 1994377-day reviewClass I21 CFR 862.1475

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Helena Laboratories · JHO Electrophoretic Separation, Lipoproteins

Cleared on Nov 10, 1994 after a 377-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided: Nov 10, 1994
Review: 377 days
Class: Class I
Product code: JHO
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK935162 Rep Direct-Sep Cholesterol-15 Kit; Cholesterol-8 Kit; Cholesterol-4…Helena Laboratories · 1994
Descendant · cites it directly · 0 of its ownK991083 RLP Cholesterol Immunoseparation AssayOtsuka Pharmaceutical Co., Ltd. · 1999

Most influential descendants

Showing 1 of 1 · See all

K991083RLP Cholesterol Immunoseparation AssayOtsuka Pharmaceutical Co., Ltd. · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K935162	Rep Direct-Sep Cholesterol-15 Kit; Cholesterol-8 Kit; Cholesterol-4 Kit	Helena Laboratories	1994	—
+1	K991083	RLP Cholesterol Immunoseparation Assay	Otsuka Pharmaceutical Co., Ltd.	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K935162, 1994–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

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Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K991083	RLP Cholesterol Immunoseparation Assay	Otsuka Pharmaceutical Co., Ltd.	1999	0

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 devices

JHO 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	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K935162 · printed Nov 4, 2026

Cite this page

510(k) Report. “K935162: Rep Direct-Sep Cholesterol-15 Kit; Cholesterol-8 Kit; Cholesterol-4 Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K935162

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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