510(k) Report

510(k) · Cleared

Cleared

Elite Test Strips Glucometer

K924499510(k) TraditionalCleared Dec 17, 1992104-day reviewClass II21 CFR 862.1345

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

Heraeus Kulzer, Inc. · CGA Glucose Oxidase, Glucose

Cleared on Dec 17, 1992 after a 104-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Dec 17, 1992
Review
104 days
Class
Class II
Product code
CGA
Recalls
None
Predicates
0

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

Descendants, by year cleared 1999: 1 descendant cleared1990200020102020
  1. This deviceK924499 Elite Test Strips GlucometerHeraeus Kulzer, Inc. · 1992
  2. Descendant · cites it directly · 0 of its ownK991480 Excel GE Blood Glucose Test Strips & Code StripSelfcare, Inc. · 1999

Most influential descendants

Showing 1 of 1 · See all
  • K991480Excel GE Blood Glucose Test Strips & Code StripSelfcare, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924499Elite Test Strips GlucometerHeraeus Kulzer, Inc.1992—
+1K991480Excel GE Blood Glucose Test Strips & Code StripSelfcare, Inc.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
FIG. 1 — Lineage of K924499, 1992–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
Get a 510(k) 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K991480Excel GE Blood Glucose Test Strips & Code StripSelfcare, Inc.19990

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, K991480 (Selfcare, Inc., 1999) 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 Heraeus Kulzer, Inc.

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  • K052543Heraceram ZirkoniaHeraeus Kulzer, Inc. · 2005
  • K043504PalaimpactHeraeus Kulzer, Inc. · 2005

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https://510kreport.com/device/K924499 · printed Nov 4, 2026

Cite this page

510(k) Report. “K924499: Elite Test Strips Glucometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K924499

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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