510(k) Report

510(k) · Cleared

Recalled · 2005

One Touch Ultrasmart Blood Glucose Monitoring System

K021819510(k) TraditionalCleared Aug 23, 200280-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 Aug 23, 2002 as substantially equivalent to K002134 (Selfcare, Inc., 2000) and 1 other predicate after an 80-day review. Its family tree reaches back 1 generation to 1995. 26 later devices descend from it. It has been recalled once.

Decided
Aug 23, 2002
Review
80 days
Class
Class II
Product code
NBW
Recalls
1
Predicates
2

Its longest line of descent runs back 1 generation to K950727 (1995). 2 ancestors in all. 26 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2008: 4 descendants cleared2009: 3 descendants cleared2011: 2 descendants cleared2012: 3 descendants cleared2010: 1 descendant cleared2016: 2 descendants cleared2013: 1 descendant cleared2014: 3 descendants cleared2015: 1 descendant cleared2017: 1 descendant cleared2020: 1 descendant cleared2022: 1 descendant cleared2025: 2 descendants cleared2024: 1 descendant clearedK950727 · One Touch Profile Complete Diabetes Tracking System · Lifescan, Inc. · 19951995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 7 descendants3 generations forward: 6 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant7 generations forward: 1 descendant8 generations forward: 1 descendant9 generations forward: 2 descendants10 generations forward: 1 descendant K950727 · One Touch Profile Complete Diabetes Tracking System · Lifescan, Inc. · 19950+5+10
  1. Root · 1 generation backK950727 One Touch Profile Complete Diabetes Tracking SystemLifescan, Inc. · 1995
  2. This deviceK021819 One Touch Ultrasmart Blood Glucose Monitoring SystemLifescan, Inc. · 2002
  3. Descendant · cites it directly · 21 of its ownK072369 Evolution Blood Glucose Monitoring SystemHmd Biomedical, LLC · 2008
  4. Descendant · 2 generations on · 10 of its ownK081703 Myglucohealth Glucose Monitoring SystemsEntra Health Systems, Ltd. · 2009
  5. Descendant · 3 generations on · 8 of its ownK113105 Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2011
  6. Descendant · 4 generations on · 7 of its ownK152124 Tempus IC2Remote Diagnostics Technologies, Ltd. · 2015
  7. Descendant · 5 generations on · 6 of its ownK152645 Dictum HealthDictum Health, Inc. · 2016

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2008: 42009: 32010: 12011: 22012: 32013: 12014: 32015: 12016: 22017: 12020: 12022: 12024: 12025: 2
2008high 4 (2008) · low 0 (2018)2026

Most influential descendants

Showing 5 of 26 · See all
  • K072369Evolution Blood Glucose Monitoring SystemHmd Biomedical, LLC · 2008 · cites it directly21descendants
  • K081703Myglucohealth Glucose Monitoring SystemsEntra Health Systems, Ltd. · 2009 · 2 generations on10descendants
  • K113105Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2011 · 3 generations on8descendants
  • K152124Tempus IC2Remote Diagnostics Technologies, Ltd. · 2015 · 4 generations on7descendants
  • K152645Dictum HealthDictum Health, Inc. · 2016 · 5 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K950727One Touch Profile Complete Diabetes Tracking SystemLifescan, Inc.1995—
0 (this device)K021819One Touch Ultrasmart Blood Glucose Monitoring SystemLifescan, Inc.2002—
+1K072369Evolution Blood Glucose Monitoring SystemHmd Biomedical, LLC2008—
+2K081703Myglucohealth Glucose Monitoring SystemsEntra Health Systems, Ltd.2009—
+3K113105Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd.2011—
+4K152124Tempus IC2Remote Diagnostics Technologies, Ltd.2015—
+5K152645Dictum HealthDictum Health, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200840
200930
201010
201120
201230
201310
201430
201510
201620
201710
202010
202210
202410
202520
FIG. 1 — Lineage of K021819, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K002134One Touch Ultra Blood Glucose Monitoring SystemSelfcare, Inc.2000—
*K950727One Touch Profile Complete Diabetes Tracking System
Summary page 1
…se detection and have the same safety and effectiveness. In addition, it is substantially equivalent to the One Touch@ Profile@(K950727) Blood Glucose Monitoring System, a predicate device with similar advanced memory features. Description of…
Lifescan, Inc.1995—

Also cleared against K002134: 9 other devices →

What descends from it? (26)

See all 26

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

NumberDeviceApplicantDecidedDescendants
K072369Evolution Blood Glucose Monitoring SystemHmd Biomedical, LLC200821
K080639Symphony Glucose Management SystemAnimas Corp.20082
K082020Envision Blood Glucose Test SystemInfopia Co, Ltd.20080

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 9, 2005Not classifiedZ-0980-05OtherMeter labeling (Owner's Booklet and Quick Reference Guide) is incorrect as it indicates that the meter displays the message 'Do you need a snack' for glucose values between 20 and 70 mg/dL; whereas the OneTouch UltraSmart meter displays…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K072369 (Hmd Biomedical, LLC, 2008) has gone furthest, with 21 descendants of its own.
  • 9 other devices also cite its predicate K002134.

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.

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 One Touch® UltraSmart™ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The One Touch® UltraSmart™ System is intended for use outside the body (for in vitro diagnostic use) by people with diabetes at home and by health care professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The One Touch® UltraSmart™ Blood Glucose Monitoring…

Read the full statement (121 words)

The One Touch® UltraSmart™ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The One Touch® UltraSmart™ System is intended for use outside the body (for in vitro diagnostic use) by people with diabetes at home and by health care professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.

The One Touch® UltraSmart™ Blood Glucose Monitoring System provides the user with electronic logbook functions that store data such as insulin and oral medication doses, food intake, amount of exercise, and health information such as illnesses. The meter includes a data port that enables the user to download electronic logbook data to a personal computer.

Indications for use as stated in the FDA summary.

Also cleared against K002134

9 other devices cite the same predicate.

  • K160179VivaChek Ino Blood Glucose Monitoring SystemVivachek Laboratories, Inc. · 2017
  • K113636Blood Glucose Monitoring System (Glucose Oxidase)Philosys Co., Ltd. · 2013
  • K123010ON Call Vivid Blood Glucose Monitoring SystemACON Laboratories, Inc. · 2012
  • K112653ON Call Vivid Blood Glucose Monitoring SystemsACON Laboratories, Inc. · 2012
  • K111371ON Call Chosen Blood Glucose Monitoring SystemACON Laboratories, Inc. · 2011
  • K090057ON-Call Plus Blood Glucose Monitoring SystemAcon Laboratories Co. · 2009

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/K021819 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021819: One Touch Ultrasmart 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/K021819

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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