510(k) · Cleared

Cleared

Easygluco Igm-0002 G2

K043512510(k) TraditionalCleared Apr 8, 2005109-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

American Healthcare, Inc. · CGA Glucose Oxidase, Glucose

Cleared on Apr 8, 2005 as substantially equivalent to K024194 (Lifescan, Inc., 2003) and 2 other predicates after a 109-day review. Its family tree reaches back 2 generations to 1995.

Decided: Apr 8, 2005
Review: 109 days
Class: Class II
Product code: CGA
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K942455 (1995). 5 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK942455 Lifescan Surestep Blood Glucose Monitoring SystemLifescan, Inc. · 1995
1 generation backK984261 Surestep Blood Glucose Monitoring SystemLifescan, Inc. · 1999
This deviceK043512 Easygluco Igm-0002 G2American Healthcare, Inc. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K942455	Lifescan Surestep Blood Glucose Monitoring System	Lifescan, Inc.	1995	—
−1	K984261	Surestep Blood Glucose Monitoring System	Lifescan, Inc.	1999	—
0 (this device)	K043512	Easygluco Igm-0002 G2	American Healthcare, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2002	1	0
2003	1	0

FIG. 1 — Lineage of K043512, 1995–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K024194	One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems Summary page 2 …The EASYGLUCO Blood Glucose Monitoring System is substantially equivalent to the following predicate devices: K024194 - LifeScan, Inc. OneTouch® Ultra® K984261 - LifeScan, Inc. SURESTEP® K021513 -…	Lifescan, Inc.	2003	5
*	K984261	Surestep Blood Glucose Monitoring System Summary page 2 …substantially equivalent to the following predicate devices: K024194 - LifeScan, Inc. OneTouch® Ultra® K984261 - LifeScan, Inc. SURESTEP® K021513 - Roche Diagnostics Corp. Accu-Chek Advantage Confidential…	Lifescan, Inc.	1999	—
*	K021513	Accu-Chek Advantage Module Summary page 2 …redicate devices: K024194 - LifeScan, Inc. OneTouch® Ultra® K984261 - LifeScan, Inc. SURESTEP® K021513 - Roche Diagnostics Corp. Accu-Chek Advantage Confidential Page 57…	Roche Diagnostics Corp.	2002	—

Also cleared against K024194: 14 other devices →

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.

What does this lineage say?

The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 5.9 years on median.
2 of the 5 ancestors have a recall of any class.
14 other devices also cite its predicate K024194.

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

2007high 10 (2009) · low 0 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CGA

249in 2023

2007high 441 (2013) · low 56 (2008)2026

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

Recalls per year · CGA

3in 2023

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	7	122	2	29
2008	6	56	2	37
2009	10	155	4	75
2010	8	122	6	172
2011	9	217	3	423
2012	10	123	0	233
2013	3	441	3	172
2014	5	265	2	122
2015	4	150	6 (2)	155
2016	4	157	2	36
2017	2	—	0	92
2018	2	—	0	69
2019	2	—	1	116
2020	2	—	0	68
2021	1	—	0	48
2022	1	—	0	272
2023	4	249	3	1,141
2024	2	—	0	266
2025	0	—	0	59
2026	1	—	0	—

What is it indicated for?

The EASYGLUCO Blood Glucose Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. The EASYGLUCO Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm, palm, thigh, and calf

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K043512 · printed Nov 5, 2026

Cite this page

510(k) Report. “K043512: Easygluco Igm-0002 G2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043512

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)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026