510(k) Report

510(k) · Cleared

Cleared

Total Cholesterol, HDL Cholesterol, Triglycerides and Glucose Panel

K946067510(k) TraditionalCleared Feb 22, 199599-day reviewClass I21 CFR 862.1175

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

Cholestech Corp. · CHH Enzymatic Esterase--Oxidase, Cholesterol

Cleared on Feb 22, 1995 after a 99-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
Feb 22, 1995
Review
99 days
Class
Class I
Product code
CHH
Recalls
None
Predicates
0

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

Descendants, by year cleared 2008: 1 descendant cleared1995200020052010201520202025
  1. This deviceK946067 Total Cholesterol, HDL Cholesterol, Triglycerides and Glucose PanelCholestech Corp. · 1995
  2. Descendant · cites it directly · 0 of its ownK080125 Apolowako T-Cho, HDL-C, TG and Analyzer, Models 993-23501…Wako Chemicals USA, Inc. · 2008

Most influential descendants

Showing 1 of 1 · See all
  • K080125Apolowako T-Cho, HDL-C, TG and Analyzer, Models 993-23501, 999-23601, 995-23701 and…Wako Chemicals USA, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K946067Total Cholesterol, HDL Cholesterol, Triglycerides and Glucose PanelCholestech Corp.1995—
+1K080125Apolowako T-Cho, HDL-C, TG and Analyzer, Models 993-23501, 999-23601…Wako Chemicals USA, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
FIG. 1 — Lineage of K946067, 1995–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 CHH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new CHH device

  1. #1 K251091 Lipidsscore 10.9 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

NumberDeviceApplicantDecidedDescendants
K080125Apolowako T-Cho, HDL-C, TG and Analyzer, Models 993-23501, 999-23601, 995-23701 and…Wako Chemicals USA, Inc.20080

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, K080125 (Wako Chemicals USA, Inc., 2008) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CHH devices

CHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CHH

1in 2025

2007: 22008: 22009: 12011: 12012: 42013: 12014: 12015: 12016: 12017: 12018: 22019: 12022: 12024: 12025: 1
2007high 4 (2012) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CHH

198in 2012

2012: 198 days median
2007high 198 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CHH

2in 2021

2009: 32010: 22013: 12014: 12016: 22021: 22026 (partial year): 1
2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CHH

14in 2025

2007: 12010: 102011: 182012: 112014: 12016: 52017: 22018: 12019: 52020: 12021: 22022: 42023: 42024: 82025: 14
2007high 18 (2011) · low 0 (2008)2025

MAUDE reports naming product code CHH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—01
20082—00
20091—30
20100—210
20111—018
20124198011
20131—10
20141—11
20151—00
20161—25
20171—02
20182—01
20191—05
20200—01
20210—22
20221—04
20230—04
20241—08
20251—014
20260—1—

More from Cholestech Corp.

20 FDA decisions under this applicant name. See the company

  • K040579Choletech LDX High-Sensitivity C-Reactive Protein (HS-CRP)Cholestech Corp. · 20042 recalls
  • K032027Cholestech LDX Aspartate Aminotransferase (Ast)Cholestech Corp. · 20031 recall
  • K991834Cholestech LDX Alanine Aminotransferase (Alt), Model 11-772Cholestech Corp. · 19991 recall
  • K972012Cholestech Bun/Creatinine Test SystemCholestech Corp. · 1997
  • K954778Cholestech LDX SystemCholestech Corp. · 1995

Recent decisions in CHH

The CHH category page

  • K251091LipidsTruvian Health · 2025
  • K232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.A · 2024
  • K203597Cholesterol2Abbott Ireland Diagnostics Division · 2022
  • K190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc. · 2019
  • K181373Extended Lipid Panel AssayLaboratory Corporation of America Holdings · 2018

https://510kreport.com/device/K946067 · printed Nov 5, 2026

Cite this page

510(k) Report. “K946067: Total Cholesterol, HDL Cholesterol, Triglycerides and Glucose Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K946067

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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