510(k) Report

510(k) · Cleared

Cleared

Onetouch Reveal Diabetes Management Application

K120558510(k) TraditionalCleared Feb 7, 2013349-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 7, 2013 as substantially equivalent to K100066 (Welldoc, Inc., 2010) after a 349-day review. Its family tree reaches back 3 generations to 2000.

Decided
Feb 7, 2013
Review
349 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K001907 (2000). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor2007: 1 other ancestorReference device: K110637 · Onetouch Verio (TM) IQ Blood Glucose Monitoring System · Cilag GmbH International · 2011 · recalledK001907 · Camit Diabetes Management Software · Roche Diagnostics Corp. · 2000K080227 · Accu-Chek 360 Diabetes Management System · Roche Diagnostics Corp. · 2008K100066 · Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1 · Welldoc, Inc. · 20102000200520102015
Other ancestors, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor K100066 · Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1 · Welldoc, Inc. · 2010K080227 · Accu-Chek 360 Diabetes Management System · Roche Diagnostics Corp. · 2008K001907 · Camit Diabetes Management Software · Roche Diagnostics Corp. · 20000
  1. Root · 3 generations backK001907 Camit Diabetes Management SoftwareRoche Diagnostics Corp. · 2000
  2. 2 generations backK080227 Accu-Chek 360 Diabetes Management SystemRoche Diagnostics Corp. · 2008
  3. 1 generation backK100066 Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1Welldoc, Inc. · 2010
  4. This deviceK120558 Onetouch Reveal Diabetes Management ApplicationLifescan, Inc. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K001907Camit Diabetes Management SoftwareRoche Diagnostics Corp.2000—
−2K080227Accu-Chek 360 Diabetes Management SystemRoche Diagnostics Corp.2008—
−1K100066Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1Welldoc, Inc.2010—
0 (this device)K120558Onetouch Reveal Diabetes Management ApplicationLifescan, Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200510
200710
FIG. 1 — Lineage of K120558, 2000–2013Source: 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
*K100066Diabetesmanager System, Diabetesmanager-RX System Model Version 1.1
Summary page 2
…nders to prompt you to complete certain tasks. Predicate Device Diabetes~vanager®o System, WelDoc, Inc. (K100066) Intended Use/indications for Use The OneTouch® Reveal Diabetes Management Applicatio…
Welldoc, Inc.2010—
†K110637Onetouch Verio (TM) IQ Blood Glucose Monitoring SystemCilag GmbH International20111

Also cleared against K100066: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 13 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
  • None of the 5 ancestors has a recall.
  • 2 other devices also cite its predicate K100066.

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. 2013, 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® Reveal Diabetes Management Application is a software accessory to the OneTouch® Verio Sync Blood Glucose Monitoring System, and is intended for use in the home setting by people with diabetes. It is intended to aid in the review, analysis, and evaluation of patient data to support diabetes management. The OneTouch® Reveal Diabetes Management Application receives (from both manual entry and wireless transmission), stores, and sends patient…

Read the full statement (105 words)

The OneTouch® Reveal Diabetes Management Application is a software accessory to the OneTouch® Verio Sync Blood Glucose Monitoring System, and is intended for use in the home setting by people with diabetes. It is intended to aid in the review, analysis, and evaluation of patient data to support diabetes management. The OneTouch® Reveal Diabetes Management Application receives (from both manual entry and wireless transmission), stores, and sends patient data for display and reporting. The OneTouch® Reveal Diabetes Management Application also communicates with web-based applications. The OneTouch® Reveal Diabetes Management Application is available for use on commercially-available mobile devices and uses generally-available networks and communication protocols

Indications for use as stated in the FDA summary.

Also cleared against K100066

2 other devices cite the same predicate.

  • K162532WellDoc BlueStar, WellDoc BlueStar RxWelldoc, Inc. · 2017
  • K162225WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx SystemWelldoc, Inc. · 2016

More from Lifescan, Inc.

42 FDA decisions under this applicant name. See the company

  • K132618Onetouch RevealLifescan, Inc. · 2013
  • K093745One Touch Verio Blood Glucose Monitoring SystemLifescan, Inc. · 2011
  • 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/K120558 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120558: Onetouch Reveal Diabetes Management Application.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120558

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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