510(k) Report

510(k) · Cleared

Cleared

Onetouch Ultralink Blood Glucose Monitoring System

K073231510(k) TraditionalCleared Apr 18, 2008155-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 Apr 18, 2008 as substantially equivalent to K053529 (Lifescan, Inc., 2006) and 1 other predicate after a 155-day review. Its family tree reaches back 2 generations to 2003. 15 later devices descend from it.

Decided
Apr 18, 2008
Review
155 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K030531 (2003). 3 ancestors in all. 15 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2012: 3 descendants cleared2013: 1 descendant cleared2015: 1 descendant cleared2016: 2 descendants cleared2019: 1 descendant cleared2021: 2 descendants cleared2022: 1 descendant cleared2023: 1 descendant cleared2024: 2 descendants cleared2026: 1 descendant clearedK030531 · Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link Glucose Meter · Minimed, Inc. · 2003 · recalledK040603 · Paradigm Link Blood Glucose Meter · Becton, Dickinson & CO · 2004200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants5 generations forward: 2 descendants6 generations forward: 3 descendants7 generations forward: 1 descendant8 generations forward: 1 descendant K040603 · Paradigm Link Blood Glucose Meter · Becton, Dickinson & CO · 2004K030531 · Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link Glucose Meter · Minimed, Inc. · 2003 · recalled0+5
  1. Root · 2 generations backK030531 Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD…Minimed, Inc. · 2003 · Recalled
  2. 1 generation backK040603 Paradigm Link Blood Glucose MeterBecton, Dickinson & CO · 2004
  3. This deviceK073231 Onetouch Ultralink Blood Glucose Monitoring SystemLifescan, Inc. · 2008
  4. Descendant · cites it directly · 13 of its ownK110894 Contour Next Link Wireless Blood Glucose MeterBayer Healthcare · 2012
  5. Descendant · 2 generations on · 10 of its ownK121087 Contour Next Usb Blood Glucose Monitoring SystemBayer Healthcare · 2012
  6. Descendant · 3 generations on · 9 of its ownK150942 Contour Next USB Blood Glucose Monitoring SystemBayer Healthcare · 2015
  7. Descendant · 4 generations on · 8 of its ownK160682 CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2016
  8. Descendant · 5 generations on · 5 of its ownK193407 Contour® next GEN Blood Glucose Monitoring SystemAscensia Diabetes Care · 2021 · Recalled

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2012: 32013: 12015: 12016: 22019: 12021: 22022: 12023: 12024: 22026: 1
2012high 3 (2012) · low 0 (2014)2026

Most influential descendants

Showing 5 of 15 · See all
  • K110894Contour Next Link Wireless Blood Glucose MeterBayer Healthcare · 2012 · cites it directly13descendants
  • K121087Contour Next Usb Blood Glucose Monitoring SystemBayer Healthcare · 2012 · 2 generations on10descendants
  • K150942Contour Next USB Blood Glucose Monitoring SystemBayer Healthcare · 2015 · 3 generations on9descendants
  • K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care · 2016 · 4 generations on8descendants
  • K193407Contour® next GEN Blood Glucose Monitoring SystemAscensia Diabetes Care · 2021 · 5 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K030531Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link…Minimed, Inc.20033
−1K040603Paradigm Link Blood Glucose MeterBecton, Dickinson & CO2004—
0 (this device)K073231Onetouch Ultralink Blood Glucose Monitoring SystemLifescan, Inc.2008—
+1K110894Contour Next Link Wireless Blood Glucose MeterBayer Healthcare2012—
+2K121087Contour Next Usb Blood Glucose Monitoring SystemBayer Healthcare2012—
+3K150942Contour Next USB Blood Glucose Monitoring SystemBayer Healthcare2015—
+4K160682CONTOUR NEXT ONE Blood Glucose Monitoring SystemAscensia Diabetes Care2016—
+5K193407Contour® next GEN Blood Glucose Monitoring SystemAscensia Diabetes Care20211

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201230
201310
201510
201620
201910
202120
202210
202310
202420
202610
FIG. 1 — Lineage of K073231, 2003–2026Source: 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
…alence The OneTouch®RUltraLink TM Blood Glucose Monitoring System is substantially equivalent to the OneTouchcR Ultra®'2 Blood Glucose Monitoring System as cleared under K053529. Both devices have a similar intended use, measure the same sample type and have similar performance characteristics. The OneTouc…
Lifescan, Inc.2006—
*K040603Paradigm Link Blood Glucose Meter
Summary page 1
…e characteristics. The OneTouch®RUltraLinkT m Blood Glucose Monitoring System is substantially equivalent to the BD Paradigm Link® Blood Glucose Monitor as cleared under K040603 for the ability to transmit blood glucose results using Radio-Frequency telemetry. Device Description The OneTouch®'UltraLink Tm…
Becton, Dickinson & CO2004—

Also cleared against K053529: 5 other devices →

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K110894Contour Next Link Wireless Blood Glucose MeterBayer Healthcare201213
K110587Contour Link Blood Glucose Meter, Contour Blood Glucose Test Strips, Contour Control…Bayer Healthcare, LLC20120

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 5 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K110894 (Bayer Healthcare, 2012) has gone furthest, with 13 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. 2008, 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 UltraLink TM Blood Glucose Monitoring System is intended to be used for self-testing outside the body (in vitro diagnostic use) for the quantitative measurement of glucose in fresh capillary whole blood obtained from the finger, forearm or palm. The OneTouch® UltraLink TM System is intended for use by people with diabetes in a home setting and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.

The OneTouch® UltraLinkTM Blood Glucose monitor may be used to transmit glucose values to appropriate MiniMed Paradigm® and Guardian® REAL Time devices using radio frequency communication.

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
  • K093745One Touch Verio Blood Glucose Monitoring SystemLifescan, Inc. · 2011
  • K082513Onetouch Vita Blood Glucose Monitoring SystemLifescan, Inc. · 2008
  • K080639Symphony Glucose Management SystemAnimas Corp. · 20087 recalls

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/K073231 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073231: Onetouch Ultralink 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/K073231

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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