510(k) · Cleared
ClearedOnetouch Verio Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cilag GmbH International · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Aug 30, 2013 as substantially equivalent to K110637 (Cilag GmbH International, 2011) after a 109-day review. Its family tree reaches back 3 generations to 2006. 6 later devices descend from it.
- Decided
- Aug 30, 2013
- Review
- 109 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K053529 (2006). 4 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK053529 Onetouch Ultra 2 Blood Glucose Monitoring SystemLifescan, Inc. · 2006
- 2 generations backK093745 One Touch Verio Blood Glucose Monitoring SystemLifescan, Inc. · 2011
- 1 generation backK110637 Onetouch Verio (TM) IQ Blood Glucose Monitoring SystemCilag GmbH International · 2011 · Recalled
- This deviceK131363 Onetouch Verio Blood Glucose Monitoring SystemCilag GmbH International · 2013
- Descendant · cites it directly · 4 of its ownK150214 OneTouch Verio Flex Blood Glucose Monitoring SystemLifescan Europe · 2015
- Descendant · 2 generations on · 1 of its ownK193475 OneTouch Verio Reflect Blood Glucose Monitoring SystemLifescan Europe GmbH · 2020
- Descendant · 3 generations on · 0 of its ownK240640 Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood…Sejoy Biomedical Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK173658 Confidence Blood Glucose Monitoring SystemApplied Biomedical, LLC · 2018
- Descendant · 2 generations on · 0 of its ownK162564 Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood…Tianjin Empecs Medical Device Co., Ltd. · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K150214OneTouch Verio Flex Blood Glucose Monitoring SystemLifescan Europe · 2015 · cites it directly4descendants
- K193475OneTouch Verio Reflect Blood Glucose Monitoring SystemLifescan Europe GmbH · 2020 · 2 generations on1descendant
- K240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd. · 2024 · 3 generations on0descendants
- K173658Confidence Blood Glucose Monitoring SystemApplied Biomedical, LLC · 2018 · 2 generations on0descendants
- K162564Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring…Tianjin Empecs Medical Device Co., Ltd. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K053529 | Onetouch Ultra 2 Blood Glucose Monitoring System | Lifescan, Inc. | 2006 | — |
| −2 | K093745 | One Touch Verio Blood Glucose Monitoring System | Lifescan, Inc. | 2011 | — |
| −1 | K110637 | Onetouch Verio (TM) IQ Blood Glucose Monitoring System | Cilag GmbH International | 2011 | 1 |
| 0 (this device) | K131363 | Onetouch Verio Blood Glucose Monitoring System | Cilag GmbH International | 2013 | — |
| +1 | K150214 | OneTouch Verio Flex Blood Glucose Monitoring System | Lifescan Europe | 2015 | — |
| +2 | K193475 | OneTouch Verio Reflect Blood Glucose Monitoring System | Lifescan Europe GmbH | 2020 | — |
| +3 | K240640 | Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose… | Sejoy Biomedical Co., Ltd. | 2024 | — |
| +2 | K173658 | Confidence Blood Glucose Monitoring System | Applied Biomedical, LLC | 2018 | — |
| +2 | K162564 | Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose… | Tianjin Empecs Medical Device Co., Ltd. | 2017 | — |
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 |
|---|---|---|
| 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 NBW? 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 NBW device
- #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K110637 | Onetouch Verio (TM) IQ Blood Glucose Monitoring SystemSummary page 6…se, performance, safety, effectiveness and the underlying scientific and operating principles used, to the predicate OneTouch®D Verio®IQ Blood Glucose Monitoring System (K 110637). LifieScan Europe, a Div. of Cilag GmbH International Page 6 of 6 21 DEPARTMENT OF HE… | 2011 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K150214 (Lifescan Europe, 2015) has gone furthest, with 4 descendants of its own.
How does its category compare?
All NBW devicesNBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · NBW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBW
243in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBW
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NBW
4,745in 2025
MAUDE reports naming product code NBW, 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 | 29 | 85 | 9 | 7,991 |
| 2008 | 37 | 128 | 2 | 7,704 |
| 2009 | 38 | 140 | 5 | 10,963 |
| 2010 | 31 | 132 | 11 | 11,631 |
| 2011 | 30 | 328 | 1 | 22,909 |
| 2012 | 30 | 230 | 1 | 23,449 |
| 2013 | 47 | 167 | 5 (2) | 35,408 |
| 2014 | 24 | 202 | 1 | 38,524 |
| 2015 | 32 | 237 | 0 | 62,111 |
| 2016 | 20 | 233 | 1 | 76,621 |
| 2017 | 25 | 244 | 0 | 37,538 |
| 2018 | 19 | 168 | 0 | 16,911 |
| 2019 | 10 | 127 | 14 | 14,472 |
| 2020 | 7 | 121 | 0 | 10,703 |
| 2021 | 7 | 465 | 0 | 9,198 |
| 2022 | 12 | 410 | 0 | 8,103 |
| 2023 | 5 | 193 | 0 | 7,256 |
| 2024 | 7 | 243 | 0 | 6,220 |
| 2025 | 2 | — | 1 | 4,745 |
| 2026 | 5 | 190 | 0 | — |
What is it indicated for?
The OneTouche Verioo 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 fingertip. The system is intended to be used by a single patient and should not be shared. The OneTouch® Verioo 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…
Read the full statement (132 words)
The OneTouche Verioo 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 fingertip. The system is intended to be used by a single patient and should not be shared.
The OneTouch® Verioo 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 OneTouche Verio® Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes or for neonatal use.
The OneToucho Veria® Test Strips are for use with the OneTouch® Verio® Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whale drawn from the fingertips.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131363: Onetouch Verio 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/K131363
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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