510(k) · Cleared

Cleared

Autosure Voice Blood Glucose Monitoring System, Model AS90011F9

K090043510(k) SpecialCleared Apr 9, 200992-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

Apex BioTechnology Corp. · CGA Glucose Oxidase, Glucose

Cleared on Apr 9, 2009 after a 92-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided: Apr 9, 2009
Review: 92 days
Class: Class II
Product code: CGA
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK090043 Autosure Voice Blood Glucose Monitoring System, Model AS90011F9Apex BioTechnology Corp. · 2009
Descendant · cites it directly · 1 of its ownK091914 Omnis Health Embrace Glucose Control SolutionBionostics, Inc. · 2009
Descendant · 2 generations on · 0 of its ownK133197 Fdi Level I and Level II Glucose Controls for the Embrace NO CodeFujirebio Diagnostics,Inc. · 2014

Most influential descendants

Showing 2 of 2 · See all

K091914Omnis Health Embrace Glucose Control SolutionBionostics, Inc. · 2009 · cites it directly1descendant
K133197Fdi Level I and Level II Glucose Controls for the Embrace NO CodeFujirebio Diagnostics,Inc. · 2014 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K090043	Autosure Voice Blood Glucose Monitoring System, Model AS90011F9	Apex BioTechnology Corp.	2009	—
+1	K091914	Omnis Health Embrace Glucose Control Solution	Bionostics, Inc.	2009	—
+2	K133197	Fdi Level I and Level II Glucose Controls for the Embrace NO Code	Fujirebio Diagnostics,Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2014	1	0

FIG. 1 — Lineage of K090043, 2009–2014Source: 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

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What was it cleared against? (1)

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
*	—	GlucoSure Voice BGM System Named without a submission number			—

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K091914	Omnis Health Embrace Glucose Control Solution	Bionostics, Inc.	2009	1

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, K091914 (Bionostics, Inc., 2009) has gone furthest, with 1 descendant 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. 2009, this device’s year, is highlighted.

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?

AutoSure Voice Blood Glucose Monitoring System: The AutoSure Voice Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Testing is done outside the body (In Vitro diagnostic use). The meter includes voice functionality to assist visually impaired users. It is indicated for both lay use by people with diabetes and in a clinical setting by…

Read the full statement (180 words)

AutoSure Voice Blood Glucose Monitoring System:

The AutoSure Voice Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Testing is done outside the body (In Vitro diagnostic use). The meter includes voice functionality to assist visually impaired users. It is indicated for both lay use by people with diabetes and in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

AutoSure Voice Test Strips:

The AutoSure Voice Blood Glucose Test Strips are to be used with the AutoSure Voice Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. The AutoSure Voice System is plasma-calibrated for easy comparison to lab result. The AutoSure Voice Blood Glucose Monitoring System is intended for self-testing by 1ersons with diabetes and by health care professionals. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090043 · printed Nov 4, 2026

Cite this page

510(k) Report. “K090043: Autosure Voice Blood Glucose Monitoring System, Model AS90011F9.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090043

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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