510(k) Report

510(k) · Cleared

Recalled · 2011

Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080

K062058510(k) TraditionalCleared Sep 11, 200653-day reviewClass II21 CFR 862.1345Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bayer Healthcare · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Sep 11, 2006 after a 53-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 20 later devices descend from it. It has been recalled 2 times.

Decided
Sep 11, 2006
Review
53 days
Class
Class II
Product code
NBW
Recalls
2
Predicates
1

20 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2013: 2 descendants cleared2012: 3 descendants cleared2011: 1 descendant cleared2014: 3 descendants cleared2009: 1 descendant cleared2016: 1 descendant cleared2017: 2 descendants cleared2015: 1 descendant cleared2018: 2 descendants cleared2021: 2 descendants cleared2019: 1 descendant cleared2020: 1 descendant cleared20052010201520202025
  1. This deviceK062058 Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip…Bayer Healthcare · 2006
  2. Descendant · cites it directly · 6 of its ownK130181 Gluneo Blood Glucose Monitoring System, and Professional Blood…Infopia Co, Ltd. · 2013
  3. Descendant · cites it directly · 6 of its ownK111268 Contour (R) Next Blood Glucose Monitoring SystemBayer Healthcare · 2012 · Recalled
  4. Descendant · 2 generations on · 5 of its ownK130265 Contour Next EZ Blood Glucose MeterBayer Healthcare, LLC · 2014
  5. Descendant · 2 generations on · 4 of its ownK132966 Gluneo Lite Glucose Monitoring System, Gluneo Lite Professional…Infopia Co, Ltd. · 2013
  6. Descendant · 3 generations on · 2 of its ownK162336 Contour Next EZ Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc. · 2017

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2009: 12011: 12012: 32013: 22014: 32015: 12016: 12017: 22018: 22019: 12020: 12021: 2
2009high 3 (2012) · low 0 (2010)2026

Most influential descendants

Showing 5 of 20 · See all
  • K130181Gluneo Blood Glucose Monitoring System, and Professional Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2013 · cites it directly6descendants
  • K111268Contour (R) Next Blood Glucose Monitoring SystemBayer Healthcare · 2012 · cites it directly6descendants
  • K130265Contour Next EZ Blood Glucose MeterBayer Healthcare, LLC · 2014 · 2 generations on5descendants
  • K132966Gluneo Lite Glucose Monitoring System, Gluneo Lite Professional Blood Glucose Monitoring…Infopia Co, Ltd. · 2013 · 2 generations on4descendants
  • K162336Contour Next EZ Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc. · 2017 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K062058Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080Bayer Healthcare2006—
+1K130181Gluneo Blood Glucose Monitoring System, and Professional Blood Glucose…Infopia Co, Ltd.2013—
+1K111268Contour (R) Next Blood Glucose Monitoring SystemBayer Healthcare20121
+2K130265Contour Next EZ Blood Glucose MeterBayer Healthcare, LLC2014—
+2K132966Gluneo Lite Glucose Monitoring System, Gluneo Lite Professional Blood Glucose…Infopia Co, Ltd.2013—
+3K162336Contour Next EZ Blood Glucose Monitoring SystemAscensia Diabetes Care U.S., Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201110
201230
201320
201430
201510
201610
201720
201820
201910
202010
202120
FIG. 1 — Lineage of K062058, 2006–2021Source: 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
Kept off the family treeK023657Ascensia® CONTOUR® Diabetes Care System
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 1
…Classification Code - 75 LFR, Glucose Dehydrogenase, Glucose Predicate Device: Ascensia® CONTOUR® Diabetes Care System, K023657 Device Description: The Ascensia® CONTOUR® Blood Glucose Monitoring System is used for the measur…

What descends from it? (20)

See all 20

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

NumberDeviceApplicantDecidedDescendants
K130181Gluneo Blood Glucose Monitoring System, and Professional Blood Glucose Monitoring SystemInfopia Co, Ltd.20136
K111268Contour (R) Next Blood Glucose Monitoring SystemBayer Healthcare20126
K131727Cera-Chek 1070 Blood Glucose Monitoring SystemCeragem Medisys, Inc.20141
K112916Tysonbio MD100 Blood Glucse Monitoring ,Tysonbio MD100 Pro Blood Glucise Monitoring SystemTyson Bioresearch, Inc.20120
K110587Contour Link Blood Glucose Meter, Contour Blood Glucose Test Strips, Contour Control…Bayer Healthcare, LLC20120
K101037EG V1 (BL) Self Monitoring Glucose Test System Model: EPS10017Eps Bio Technology Corp.20110
K090628Didget Blood Glucose Meter, Model 6181; Contour Blood Glucose Test Strips, Model 7080Bayer Healthcare, LLC20090

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 12, 2011Not classifiedZ-3268-2011PackagingAll 10- or 25- count glucose test strip vials, either loose vials or found in patient starter kits of Contour, Contour TS and Contour" USB blood glucose meters are being recalled a packaging issue which, under certain conditions, can…
Jun 6, 2007Not classifiedZ-1001-2007OtherIncorrect Unit of Measure displayed : The meters report results in the wrong unit of measurement for Canadian users.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K130181 (Infopia Co, Ltd., 2013) has gone furthest, with 6 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.

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 Ascensia® CONTOUR® Blood Glucose Monitoring System is used for the measurement of glucose in whole blood. The Ascensia® CONTOUR® Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities.

The Ascensia® CONTOUR® Blood Glucose Monitoring System is indicated for use with capillary, venous, and arterial whole blood samples and neonatal blood samples. Capillary samples may be drawn from the fingertip, palm, forearm, and in the case of neonates, the heel. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

Indications for use as stated in the FDA summary.

More from Bayer Healthcare

12 FDA decisions under this applicant name. See the company

  • K150942Contour Next USB Blood Glucose Monitoring SystemBayer Healthcare · 2015
  • K151742Contour Next Control SolutionBayer Healthcare · 2015
  • K122370Contour Next Link Wireless Blood Glucose MonitorBayer Healthcare · 2013
  • K121087Contour Next Usb Blood Glucose Monitoring SystemBayer Healthcare · 2012
  • K110894Contour Next Link Wireless Blood Glucose MeterBayer Healthcare · 2012

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/K062058 · printed Nov 5, 2026

Cite this page

510(k) Report. “K062058: Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062058

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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