510(k) Report

510(k) · Cleared

Recalled · 2011

Cholestech Lipid Monitoring System, Glucose Test

K904082510(k) TraditionalCleared Dec 26, 1990112-day reviewClass II21 CFR 862.1345Recalls 1

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

Cholestech Corp. · CGA Glucose Oxidase, Glucose

Cleared on Dec 26, 1990 after a 112-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided
Dec 26, 1990
Review
112 days
Class
Class II
Product code
CGA
Recalls
1
Predicates
0

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

Descendants, by year cleared 2008: 1 descendant cleared1990200020102020
  1. This deviceK904082 Cholestech Lipid Monitoring System, Glucose TestCholestech Corp. · 1990
  2. Descendant · cites it directly · 0 of its ownK080123 Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401…Wako Chemicals USA, Inc. · 2008

Most influential descendants

Showing 1 of 1 · See all
  • K080123Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201Wako Chemicals USA, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K904082Cholestech Lipid Monitoring System, Glucose TestCholestech Corp.1990—
+1K080123Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201Wako Chemicals USA, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
FIG. 1 — Lineage of K904082, 1990–2008Source: 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 CGA? 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 CGA device

  1. #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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? (1)

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

NumberDeviceApplicantDecidedDescendants
K080123Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201Wako Chemicals USA, Inc.20080

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 18, 2011Not classifiedZ-2402-2011PendingThe recall was initiated due to an issue related to an error in the encoding of calibration coefficients in the sample cassette that cause the Cholestech LDX analyzer to report glucose values as >500 mg/dL regardless of the true value of…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K080123 (Wako Chemicals USA, Inc., 2008) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CGA devices

CGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CGA

2in 2024

2007: 72008: 62009: 102010: 82011: 92012: 102013: 32014: 52015: 42016: 42017: 22018: 22019: 22020: 22021: 12022: 12023: 42024: 22026 (partial year): 1
2007high 10 (2009) · low 0 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CGA

249in 2023

2007: 122 days median2008: 56 days median2009: 155 days median2010: 122 days median2011: 217 days median2012: 123 days median2013: 441 days median2014: 265 days median2015: 150 days median2016: 157 days median2023: 249 days median
2007high 441 (2013) · low 56 (2008)2026

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

Recalls per year · CGA

3in 2023

2007: 22008: 22009: 42010: 62011: 32013: 32014: 22015: 6, 2 Class I2016: 22019: 12023: 3
2007high 6 (2010) · low 0 (2012)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · CGA

59in 2025

2007: 292008: 372009: 752010: 1722011: 4232012: 2332013: 1722014: 1222015: 1552016: 362017: 922018: 692019: 1162020: 682021: 482022: 2722023: 1,1412024: 2662025: 59
2007high 1,141 (2023) · low 29 (2007)2025

MAUDE reports naming product code CGA, 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
20077122229
2008656237
200910155475
201081226172
201192173423
2012101230233
201334413172
201452652122
201541506 (2)155
20164157236
20172—092
20182—069
20192—1116
20202—068
20211—048
20221—0272
2023424931,141
20242—0266
20250—059
20261—0—

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 CGA

The CGA category page

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  • K223179Cholestech LDX ™ SystemAlere San Diego, Inc. · 2023
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https://510kreport.com/device/K904082 · printed Nov 4, 2026

Cite this page

510(k) Report. “K904082: Cholestech Lipid Monitoring System, Glucose Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K904082

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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