510(k) · Cleared

Recalled · 2009

Accu-Chek GO System

K040796510(k) SpecialCleared Apr 22, 200424-day reviewClass II21 CFR 862.1345Recalls 2

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

Roche Diagnostics Corp. · LFR Glucose Dehydrogenase, Glucose

Cleared on Apr 22, 2004 as substantially equivalent to K031755 (Roche Diagnostics Corp., 2003) after a 24-day review. Its family tree reaches back 1 generation to 2003. 12 later devices descend from it. It has been recalled 2 times.

Decided: Apr 22, 2004
Review: 24 days
Class: Class II
Product code: LFR
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K031755 (2003). 12 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK031755 Accu-Chek Compact Test StripRoche Diagnostics Corp. · 2003
This deviceK040796 Accu-Chek GO SystemRoche Diagnostics Corp. · 2004
Descendant · cites it directly · 10 of its ownK082169 Pro Glucose Test StripTaidoc Technology Corporation · 2008
Descendant · 2 generations on · 6 of its ownK100322 TD-4277 Blood Glucose Monitoring System, Model 4277Taidoc Technology Corporation · 2010
Descendant · 3 generations on · 1 of its ownK190579 TD-4183 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2019
Descendant · 2 generations on · 1 of its ownK101259 V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002Taidoc Technology Corporation · 2010
Descendant · 4 generations on · 0 of its ownK222126 VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart…Vivachek Biotech (Hangzhou) Co., Ltd. · 2024

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2005high 3 (2018) · low 0 (2006)2026

Most influential descendants

Showing 5 of 12 · See all

K082169Pro Glucose Test StripTaidoc Technology Corporation · 2008 · cites it directly10descendants
K100322TD-4277 Blood Glucose Monitoring System, Model 4277Taidoc Technology Corporation · 2010 · 2 generations on6descendants
K190579TD-4183 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2019 · 3 generations on1descendant
K101259V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002Taidoc Technology Corporation · 2010 · 2 generations on1descendant
K222126VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose…Vivachek Biotech (Hangzhou) Co., Ltd. · 2024 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K031755	Accu-Chek Compact Test Strip	Roche Diagnostics Corp.	2003	—
0 (this device)	K040796	Accu-Chek GO System	Roche Diagnostics Corp.	2004	—
+1	K082169	Pro Glucose Test Strip	Taidoc Technology Corporation	2008	—
+2	K100322	TD-4277 Blood Glucose Monitoring System, Model 4277	Taidoc Technology Corporation	2010	—
+3	K190579	TD-4183 Blood Glucose Monitoring System	Taidoc Technology Corporation	2019	—
+2	K101259	V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002	Taidoc Technology Corporation	2010	—
+4	K222126	VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood…	Vivachek Biotech (Hangzhou) Co., Ltd.	2024	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2008	1	0
2010	2	0
2011	1	0
2012	2	0
2018	3	0
2019	1	0
2024	1	0

FIG. 1 — Lineage of K040796, 2003–2024Source: 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 LFR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

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
*	K031755	Accu-Chek Compact Test Strip Summary page 1 …(21 C.F.R. § 862.1345)(75LFR) 3) Predicate We claim substantial equivalence to the current legally marketed Accu- device Chek Compact System (K#031755). 4) Device Instrument Operating Principle -- photometry Description Reagent Test Principle -- glucose dehydrogenase…	Roche Diagnostics Corp.	2003	—

Also cleared against K031755: 2 other devices →

What descends from it? (12)

See all 12

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K082169	Pro Glucose Test Strip	Taidoc Technology Corporation	2008	10
K051592	Modification to Accu-Chek GO System	Roche Diagnostics Corp.	2005	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 13, 2009	Not classified	Z-1595-2009	Other	The lancet cap may be missing, which could result in an unintended lancet stick to the user.
Jun 7, 2005	Not classified	Z-1370-05	Other	The meter may self-start without a sample having been applied and report erroneous results without an error message if an undosed test strip is bent upwards, and held upwards, while the meter is waiting for the sample.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K082169 (Taidoc Technology Corporation, 2008) has gone furthest, with 10 descendants of its own.
2 other devices also cite its predicate K031755.

How does its category compare?

All LFR devices

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

FDA decisions per year · LFR

1in 2015

2007high 13 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LFR

161in 2014

2007high 296 (2011) · low 152 (2012)2026

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

Recalls per year · LFR

1in 2012

2007high 4 (2009) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LFR

827in 2025

2007high 23,819 (2007) · low 101 (2022)2025

MAUDE reports naming product code LFR, 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	1	—	3	23,819
2008	0	—	1	6,584
2009	1	—	4	10,823
2010	0	—	0	4,865
2011	6	296	1	3,802
2012	13	152	1	3,341
2013	3	212	0	3,821
2014	3	161	0	3,960
2015	1	—	0	3,366
2016	0	—	0	2,145
2017	0	—	0	103
2018	0	—	0	108
2019	0	—	0	108
2020	0	—	0	132
2021	0	—	0	164
2022	0	—	0	101
2023	0	—	0	103
2024	0	—	0	171
2025	0	—	0	827
2026	0	—	0	—

What is it indicated for?

The Accu-Chek Go system is designed to quantitatively measure the concentration of glucose in capillary whole blood by persons with diabetes or by health care professionals for monitoring glucose in the home or in health care facilities. The device is indicated for professional use and over-the-counter sale.

Professionals may use the test strips to test capillary and venous blood samples; lay use is limited to capillary whole blood testing.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040796 · printed Nov 3, 2026

Cite this page

510(k) Report. “K040796: Accu-Chek GO System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040796

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