510(k) Report

510(k) · Cleared

Cleared

One Touch Verio Blood Glucose Monitoring System

K093745510(k) TraditionalCleared Feb 11, 2011434-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

Lifescan, Inc. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Feb 11, 2011 as substantially equivalent to K053529 (Lifescan, Inc., 2006) and 1 other predicate after a 434-day review. Its family tree reaches back 1 generation to 2006. 9 later devices descend from it.

Decided
Feb 11, 2011
Review
434 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K053529 (2006). 2 ancestors in all. 9 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2013: 2 descendants cleared2011: 1 descendant cleared2015: 2 descendants cleared2020: 1 descendant cleared2018: 1 descendant cleared2017: 1 descendant cleared2024: 1 descendant clearedK053529 · Onetouch Ultra 2 Blood Glucose Monitoring System · Lifescan, Inc. · 200620052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant K053529 · Onetouch Ultra 2 Blood Glucose Monitoring System · Lifescan, Inc. · 20060+5
  1. Root · 1 generation backK053529 Onetouch Ultra 2 Blood Glucose Monitoring SystemLifescan, Inc. · 2006
  2. This deviceK093745 One Touch Verio Blood Glucose Monitoring SystemLifescan, Inc. · 2011
  3. Descendant · cites it directly · 7 of its ownK110637 Onetouch Verio (TM) IQ Blood Glucose Monitoring SystemCilag GmbH International · 2011 · Recalled
  4. Descendant · 2 generations on · 6 of its ownK131363 Onetouch Verio Blood Glucose Monitoring SystemCilag GmbH International · 2013
  5. Descendant · 3 generations on · 4 of its ownK150214 OneTouch Verio Flex Blood Glucose Monitoring SystemLifescan Europe · 2015
  6. Descendant · 4 generations on · 1 of its ownK193475 OneTouch Verio Reflect Blood Glucose Monitoring SystemLifescan Europe GmbH · 2020
  7. Descendant · 5 generations on · 0 of its ownK240640 Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood…Sejoy Biomedical Co., Ltd. · 2024

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2011: 12013: 22015: 22017: 12018: 12020: 12024: 1
2011high 2 (2013) · low 0 (2012)2026

Most influential descendants

Showing 5 of 9 · See all
  • K110637Onetouch Verio (TM) IQ Blood Glucose Monitoring SystemCilag GmbH International · 2011 · cites it directly7descendants
  • K131363Onetouch Verio Blood Glucose Monitoring SystemCilag GmbH International · 2013 · 2 generations on6descendants
  • K150214OneTouch Verio Flex Blood Glucose Monitoring SystemLifescan Europe · 2015 · 3 generations on4descendants
  • K193475OneTouch Verio Reflect Blood Glucose Monitoring SystemLifescan Europe GmbH · 2020 · 4 generations on1descendant
  • K240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemSejoy Biomedical Co., Ltd. · 2024 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K053529Onetouch Ultra 2 Blood Glucose Monitoring SystemLifescan, Inc.2006—
0 (this device)K093745One Touch Verio Blood Glucose Monitoring SystemLifescan, Inc.2011—
+1K110637Onetouch Verio (TM) IQ Blood Glucose Monitoring SystemCilag GmbH International20111
+2K131363Onetouch Verio Blood Glucose Monitoring SystemCilag GmbH International2013—
+3K150214OneTouch Verio Flex Blood Glucose Monitoring SystemLifescan Europe2015—
+4K193475OneTouch Verio Reflect Blood Glucose Monitoring SystemLifescan Europe GmbH2020—
+5K240640Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose…Sejoy Biomedical Co., Ltd.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201320
201520
201710
201810
202010
202410
FIG. 1 — Lineage of K093745, 2006–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K053529Onetouch Ultra 2 Blood Glucose Monitoring System
Summary page 1
…means of an electrical current produced in the test strip and sent to the meter for measurement. PREDICATE DEVICES OineTouch® Ultra®2 Blood Glucose Monitoring System (K053529) OineTouch® Select Control Solutions (K072543) INTENDED USE/INDICATIONS FOR USE The OneTouch® Ver' Tm Blood Glucose Monitoring…
Lifescan, Inc.2006—
*K072543Onetouch Select Blood Glucose Monitoring System
Summary page 1
…e test strip and sent to the meter for measurement. PREDICATE DEVICES OineTouch® Ultra®2 Blood Glucose Monitoring System (K053529) OineTouch® Select Control Solutions (K072543) INTENDED USE/INDICATIONS FOR USE The OneTouch® Ver' Tm Blood Glucose Monitoring System is intended to be used for the quantita…
Lifescan, Inc.20071

Also cleared against K053529: 5 other devices →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K110637Onetouch Verio (TM) IQ Blood Glucose Monitoring SystemCilag GmbH International20117
K120708Onetouch Verio Sync Blood Glucose Monitoring SystemCilag GmbH International20130

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K110637 (Cilag GmbH International, 2011) has gone furthest, with 7 descendants of its own.
  • 5 other devices also cite its predicate K053529.

How does its category compare?

All NBW devices

NBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · NBW

2in 2025

2007: 292008: 372009: 382010: 312011: 302012: 302013: 472014: 242015: 322016: 202017: 252018: 192019: 102020: 72021: 72022: 122023: 52024: 72025: 22026 (partial year): 5
2007high 47 (2013) · low 2 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NBW

243in 2024

2007: 85 days median2008: 128 days median2009: 140 days median2010: 132 days median2011: 328 days median2012: 230 days median2013: 167 days median2014: 202 days median2015: 237 days median2016: 233 days median2017: 244 days median2018: 168 days median2019: 127 days median2020: 121 days median2021: 465 days median2022: 410 days median2023: 193 days median2024: 243 days median2026 (partial year): 190 days median
2007high 465 (2021) · low 85 (2007)2026

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

Recalls per year · NBW

1in 2025

2007: 92008: 22009: 52010: 112011: 12012: 12013: 5, 2 Class I2014: 12016: 12019: 142025: 1
2007high 14 (2019) · low 0 (2015)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · NBW

4,745in 2025

2007: 7,9912008: 7,7042009: 10,9632010: 11,6312011: 22,9092012: 23,4492013: 35,4082014: 38,5242015: 62,1112016: 76,6212017: 37,5382018: 16,9112019: 14,4722020: 10,7032021: 9,1982022: 8,1032023: 7,2562024: 6,2202025: 4,745
2007high 76,621 (2016) · low 4,745 (2025)2025

MAUDE reports naming product code NBW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007298597,991
20083712827,704
200938140510,963
2010311321111,631
201130328122,909
201230230123,449
2013471675 (2)35,408
201424202138,524
201532237062,111
201620233176,621
201725244037,538
201819168016,911
2019101271414,472
20207121010,703
2021746509,198
20221241008,103
2023519307,256
2024724306,220
20252—14,745
202651900—

What is it indicated for?

The OneTouch® Verio 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, forearm or palm. The OneTouch® Verio Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. The OneTouch® Verio Blood Glucose Monitoring System is intended for self testing outside the body…

Read the full statement (201 words)

The OneTouch® Verio 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, forearm or palm. The OneTouch® Verio Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.

The OneTouch® Verio 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® Verio Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The OneTouch® Verio Test Strips are for use with the OneTouch® Verio Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The OneTouch® Verio Control Solutions are for use with the OneTouch® Verio Blood Glucose Meter and Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

Indications for use as stated in the FDA summary.

Also cleared against K053529

5 other devices cite the same predicate.

  • K123090GLB Benecheck Premium Glu Monitoring SystemGeneral Life Biotechnology Co., Ltd. · 2013
  • K111456Medisign Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd. · 2012
  • K082513Onetouch Vita Blood Glucose Monitoring SystemLifescan, Inc. · 2008
  • K080639Symphony Glucose Management SystemAnimas Corp. · 20087 recalls
  • K073231Onetouch Ultralink Blood Glucose Monitoring SystemLifescan, Inc. · 2008

More from Lifescan, Inc.

42 FDA decisions under this applicant name. See the company

  • K132618Onetouch RevealLifescan, Inc. · 2013
  • K120558Onetouch Reveal Diabetes Management ApplicationLifescan, Inc. · 2013
  • K082590Symphony Meter RemoteLifescan, Inc. · 2008
  • K082513Onetouch Vita Blood Glucose Monitoring SystemLifescan, Inc. · 2008
  • K081318Onetouch Zoom Diabetes Management ProgramLifescan, Inc. · 2008

Recent decisions in NBW

The NBW category page

  • K261293EASYMAX Voice Blood Glucose Monitoring SystemEPS Bio Technology Corp. · 2026
  • K260687VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual…Vivachek Biotech (Hangzhou) Co., Ltd. · 2026
  • K260689CVS Advanced PLUS Blood Glucose Monitoring SystemI-Sens, Inc. · 2026
  • K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System…Ascensia Diabetes Care · 2026
  • K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc. · 2026

https://510kreport.com/device/K093745 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093745: One Touch Verio Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093745

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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