510(k) · Cleared

Cleared

Q.Steps Biometer G Blood Glucose Monitoring System

K033627510(k) TraditionalCleared May 21, 2004184-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

Biomedix, Inc. · CGA Glucose Oxidase, Glucose

Cleared on May 21, 2004 as substantially equivalent to K031472 (Lifescan, Inc., 2003) after a 184-day review. Its family tree reaches back 1 generation to 2003. 1 later device descends from it.

Decided: May 21, 2004
Review: 184 days
Class: Class II
Product code: CGA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K031472 (2003). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK031472 One Touch Basic/Profile/One Touch II Test StripsLifescan, Inc. · 2003
This deviceK033627 Q.Steps Biometer G Blood Glucose Monitoring SystemBiomedix, Inc. · 2004
Descendant · cites it directly · 0 of its ownK050182 Q.Steps Biometer G/C Dual Monitoring SystemBiomedix, Inc. · 2005

Most influential descendants

Showing 1 of 1 · See all

K050182Q.Steps Biometer G/C Dual Monitoring SystemBiomedix, Inc. · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K031472	One Touch Basic/Profile/One Touch II Test Strips	Lifescan, Inc.	2003	—
0 (this device)	K033627	Q.Steps Biometer G Blood Glucose Monitoring System	Biomedix, Inc.	2004	—
+1	K050182	Q.Steps Biometer G/C Dual Monitoring System	Biomedix, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

FIG. 1 — Lineage of K033627, 2003–2005Source: 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
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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
*	K031472	One Touch Basic/Profile/One Touch II Test Strips	Lifescan, Inc.	2003	—

Also cleared against K031472: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K050182	Q.Steps Biometer G/C Dual Monitoring System	Biomedix, Inc.	2005	0

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?

Its one ancestor has no recall.
Of its descendants, K050182 (Biomedix, Inc., 2005) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K031472.

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 Q.STEPS™ Biometer G Blood Glucose Monitoring System is intended to be used for quantitative measurement of glucose in fresh capillary whole blood from the fingertip for all ages (excluding neonates.) It is intended for use outside the body (for in vitro diagnostic use) by health care professionals in settings such as clinical laboratories and physician offices laboratories (POLs) as an aid to monitor the effectiveness of diabetes control.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K033627 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033627: Q.Steps Biometer G Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033627

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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