510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

Onetouch Select Blood Glucose Monitoring System

K072543510(k) SpecialCleared Oct 5, 200725-day reviewClass II21 CFR 862.1345Recalls 1

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 Oct 5, 2007 after a 25-day review. The FDA summary names its predicate without a number. 12 later devices descend from it. It has been recalled once.

Decided
Oct 5, 2007
Review
25 days
Class
Class II
Product code
NBW
Recalls
1
Predicates
0

12 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2015: 3 descendants cleared2011: 2 descendants cleared2013: 2 descendants cleared2020: 1 descendant cleared2018: 1 descendant cleared2017: 1 descendant cleared2024: 1 descendant cleared20052010201520202025
  1. This deviceK072543 Onetouch Select Blood Glucose Monitoring SystemLifescan, Inc. · 2007
  2. Descendant · cites it directly · 9 of its ownK093745 One Touch Verio Blood Glucose Monitoring SystemLifescan, Inc. · 2011
  3. Descendant · 2 generations on · 7 of its ownK110637 Onetouch Verio (TM) IQ Blood Glucose Monitoring SystemCilag GmbH International · 2011 · Recalled
  4. Descendant · 3 generations on · 6 of its ownK131363 Onetouch Verio Blood Glucose Monitoring SystemCilag GmbH International · 2013
  5. Descendant · 4 generations on · 4 of its ownK150214 OneTouch Verio Flex Blood Glucose Monitoring SystemLifescan Europe · 2015
  6. Descendant · 5 generations on · 1 of its ownK193475 OneTouch Verio Reflect Blood Glucose Monitoring SystemLifescan Europe GmbH · 2020

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2008: 12011: 22013: 22015: 32017: 12018: 12020: 12024: 1
2008high 3 (2015) · low 0 (2009)2026

Most influential descendants

Showing 5 of 12 · See all
  • K093745One Touch Verio Blood Glucose Monitoring SystemLifescan, Inc. · 2011 · cites it directly9descendants
  • K110637Onetouch Verio (TM) IQ Blood Glucose Monitoring SystemCilag GmbH International · 2011 · 2 generations on7descendants
  • K131363Onetouch Verio Blood Glucose Monitoring SystemCilag GmbH International · 2013 · 3 generations on6descendants
  • K150214OneTouch Verio Flex Blood Glucose Monitoring SystemLifescan Europe · 2015 · 4 generations on4descendants
  • K193475OneTouch Verio Reflect Blood Glucose Monitoring SystemLifescan Europe GmbH · 2020 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K072543Onetouch Select Blood Glucose Monitoring SystemLifescan, Inc.2007—
+1K093745One Touch Verio Blood Glucose Monitoring SystemLifescan, Inc.2011—
+2K110637Onetouch Verio (TM) IQ Blood Glucose Monitoring SystemCilag GmbH International20111
+3K131363Onetouch Verio Blood Glucose Monitoring SystemCilag GmbH International2013—
+4K150214OneTouch Verio Flex Blood Glucose Monitoring SystemLifescan Europe2015—
+5K193475OneTouch Verio Reflect Blood Glucose Monitoring SystemLifescan Europe GmbH2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201120
201320
201530
201710
201810
202010
202410
FIG. 1 — Lineage of K072543, 2007–2024Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*—OneTouch Ultra 2 Blood Glucose Monitoring System
Named without a submission number
—

What descends from it? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K093745One Touch Verio Blood Glucose Monitoring SystemLifescan, Inc.20119
K140325Joinsoon EON L Glucose Monitoring System and Joinsoon EON LS Glucose Monitoring SystemJoinsoon Medical Technology Co, Ltd.20150
K082513Onetouch Vita Blood Glucose Monitoring SystemLifescan, Inc.20080

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 25, 2013Class IIZ-1130-2013Nonconforming Material/ComponentWhen OneTouch¿ Ultra and OneTouch¿ Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial label even though the system is…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K093745 (Lifescan, Inc., 2011) has gone furthest, with 9 descendants of its own.

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. 2007, 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 Select Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch Select System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes in a home setting and/or by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.

The OneTouch Select Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.

Indications for use as stated in the FDA summary.

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
  • K093745One Touch Verio Blood Glucose Monitoring SystemLifescan, Inc. · 2011
  • K082590Symphony Meter RemoteLifescan, Inc. · 2008
  • K082513Onetouch Vita Blood Glucose Monitoring SystemLifescan, 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/K072543 · printed Nov 5, 2026

Cite this page

510(k) Report. “K072543: Onetouch Select 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/K072543

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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