510(k) · Cleared
Recalled · 2012Onetouch Verio (TM) IQ Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cilag GmbH International · LFR Glucose Dehydrogenase, Glucose
Cleared on Sep 7, 2011 as substantially equivalent to K093745 (Lifescan, Inc., 2011) after a 187-day review. Its family tree reaches back 2 generations to 2006. 7 later devices descend from it. It has been recalled once.
- Decided
- Sep 7, 2011
- Review
- 187 days
- Class
- Class II
- Product code
- LFR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K053529 (2006). 3 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK053529 Onetouch Ultra 2 Blood Glucose Monitoring SystemLifescan, Inc. · 2006
- 1 generation backK093745 One Touch Verio Blood Glucose Monitoring SystemLifescan, Inc. · 2011
- This deviceK110637 Onetouch Verio (TM) IQ Blood Glucose Monitoring SystemCilag GmbH International · 2011
- Descendant · cites it directly · 6 of its ownK131363 Onetouch Verio Blood Glucose Monitoring SystemCilag GmbH International · 2013
- Descendant · 2 generations on · 4 of its ownK150214 OneTouch Verio Flex Blood Glucose Monitoring SystemLifescan Europe · 2015
- Descendant · 3 generations on · 1 of its ownK193475 OneTouch Verio Reflect Blood Glucose Monitoring SystemLifescan Europe GmbH · 2020
- Descendant · 4 generations on · 0 of its ownK240640 Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood…Sejoy Biomedical Co., Ltd. · 2024
- Descendant · 3 generations on · 0 of its ownK173658 Confidence Blood Glucose Monitoring SystemApplied Biomedical, LLC · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K131363Onetouch Verio Blood Glucose Monitoring SystemCilag GmbH International · 2013 · cites it directly6descendants
- K150214OneTouch Verio Flex Blood Glucose Monitoring SystemLifescan Europe · 2015 · 2 generations on4descendants
- K193475OneTouch Verio Reflect Blood Glucose Monitoring SystemLifescan Europe GmbH · 2020 · 3 generations on1descendant
- K240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd. · 2024 · 4 generations on0descendants
- K173658Confidence Blood Glucose Monitoring SystemApplied Biomedical, LLC · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K053529 | Onetouch Ultra 2 Blood Glucose Monitoring System | Lifescan, Inc. | 2006 | — |
| −1 | K093745 | One Touch Verio Blood Glucose Monitoring System | Lifescan, Inc. | 2011 | — |
| 0 (this device) | K110637 | Onetouch Verio (TM) IQ Blood Glucose Monitoring System | Cilag GmbH International | 2011 | — |
| +1 | K131363 | Onetouch Verio Blood Glucose Monitoring System | Cilag GmbH International | 2013 | — |
| +2 | K150214 | OneTouch Verio Flex Blood Glucose Monitoring System | Lifescan Europe | 2015 | — |
| +3 | K193475 | OneTouch Verio Reflect Blood Glucose Monitoring System | Lifescan Europe GmbH | 2020 | — |
| +4 | K240640 | Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose… | Sejoy Biomedical Co., Ltd. | 2024 | — |
| +3 | K173658 | Confidence Blood Glucose Monitoring System | Applied Biomedical, LLC | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K093745 | One Touch Verio Blood Glucose Monitoring SystemSummary page 2…Page I of 5 PREDICATE DEVICE OneTouch® Ver io Tm Blood Glucose Monitoring System (K093745) INTENDED USE/INDICATIONS FOR USE The OneTouch® VerioTMIQ Blood Glucose Monitoring System is intended to be used for the quanti… | 2011 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131363 | Onetouch Verio Blood Glucose Monitoring System | 2013 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 21, 2012 | Not classified | Z-1359-2012 | Software design | An error was discovered in the OneTouch IQ meter software so that the meter turns itself off when a user attempts to view results in the "Results Log" when the log has 256 or a multiple of 256 items to display. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K131363 (Cilag GmbH International, 2013) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K093745.
How does its category compare?
All LFR devicesLFR Glucose Dehydrogenase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LFR
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · LFR
161in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFR
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFR
827in 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 OneTouch® VerioTMIQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The OneTouch® VerioTM IQ Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. OneTouch® Verio TmIQ Blood Glucose Monitoring System is intended for self testing outside the body (in…
Read the full statement (142 words)
The OneTouch® VerioTMIQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The OneTouch® VerioTM IQ Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
OneTouch® Verio TmIQ Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The OneTouch® Ver io TM IQ Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes, neonatal use.
The OneTouch® Verio TM Test Strips are for use with the OneTouch® Veri o TM IQ Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110637 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110637: Onetouch Verio (TM) IQ Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110637
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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