510(k) Report

510(k) · Cleared

Cleared

Ascensia Elite Diabetes Care System

K043311510(k) SpecialCleared Dec 22, 200421-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

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

Cleared on Dec 22, 2004 as substantially equivalent to K020208 (Bayer Group Diagnostics, 2002) and 1 other predicate after a 21-day review. Its family tree reaches back 1 generation to 1997. 9 later devices descend from it.

Decided
Dec 22, 2004
Review
21 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K964630 (1997). 2 ancestors in all. 9 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2008: 2 descendants cleared2007: 1 descendant cleared2009: 1 descendant cleared2013: 1 descendant cleared2012: 4 descendants clearedK964630 · Glucometer Elite Blood Glucose Meter · Bayer Corp. · 19971995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 4 descendants K964630 · Glucometer Elite Blood Glucose Meter · Bayer Corp. · 19970
  1. Root · 1 generation backK964630 Glucometer Elite Blood Glucose MeterBayer Corp. · 1997
  2. This deviceK043311 Ascensia Elite Diabetes Care SystemBayer Healthcare, LLC · 2004
  3. Descendant · cites it directly · 6 of its ownK062538 Easy Check Blood Glucose Monitoring SystemDiacare Corp. · 2007
  4. Descendant · 2 generations on · 4 of its ownK090389 AP-1000 Blood Glucose Monitoring SystemBestgen Biotech Corp. · 2009
  5. Descendant · cites it directly · 1 of its ownK082395 Glucose Meter-Check Control Solution for Bayer Ascensia Blood…Bionostics, Inc. · 2008
  6. Descendant · 2 generations on · 0 of its ownK123966 Glucose Meter-Check Solution for BayerBionostics, Inc. · 2013
  7. Descendant · 3 generations on · 0 of its ownK103230 AP-3000 Blood Glucose Monitoring System, Major Glucose Control…Bestgen Biotech Corp. · 2012

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22009: 12012: 42013: 1
2007high 4 (2012) · low 0 (2010)2026

Most influential descendants

Showing 5 of 9 · See all
  • K062538Easy Check Blood Glucose Monitoring SystemDiacare Corp. · 2007 · cites it directly6descendants
  • K090389AP-1000 Blood Glucose Monitoring SystemBestgen Biotech Corp. · 2009 · 2 generations on4descendants
  • K082395Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002Bionostics, Inc. · 2008 · cites it directly1descendant
  • K123966Glucose Meter-Check Solution for BayerBionostics, Inc. · 2013 · 2 generations on0descendants
  • K103230AP-3000 Blood Glucose Monitoring System, Major Glucose Control SolutionBestgen Biotech Corp. · 2012 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K964630Glucometer Elite Blood Glucose MeterBayer Corp.1997—
0 (this device)K043311Ascensia Elite Diabetes Care SystemBayer Healthcare, LLC2004—
+1K062538Easy Check Blood Glucose Monitoring SystemDiacare Corp.2007—
+2K090389AP-1000 Blood Glucose Monitoring SystemBestgen Biotech Corp.2009—
+1K082395Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter…Bionostics, Inc.2008—
+2K123966Glucose Meter-Check Solution for BayerBionostics, Inc.2013—
+3K103230AP-3000 Blood Glucose Monitoring System, Major Glucose Control SolutionBestgen Biotech Corp.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
200910
201240
201310
FIG. 1 — Lineage of K043311, 1997–2013Source: 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? (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
*K020208Glucometer Elite Diabetes Care System (Modified)
Summary page 1
…se Meter Manufacturer: Bayer HealthCare LLC 430 S. Bieger Street Mishawaka, In 46544 5 10(k) Number(s): K020208/K964630 Device Description The Ascensia ELITET M Diabetes Care System consists of an electrochemical method- based meter and dr…
Bayer Group Diagnostics2002—
*K964630Glucometer Elite Blood Glucose Meter
Summary page 1
…Manufacturer: Bayer HealthCare LLC 430 S. Bieger Street Mishawaka, In 46544 5 10(k) Number(s): K020208/K964630 Device Description The Ascensia ELITET M Diabetes Care System consists of an electrochemical method- based meter and dry reagen…
Bayer Corp.1997—

Also cleared against K020208: 2 other devices →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K062538Easy Check Blood Glucose Monitoring SystemDiacare Corp.20076
K082395Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002Bionostics, Inc.20081

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K062538 (Diacare Corp., 2007) has gone furthest, with 6 descendants of its own.
  • 2 other devices also cite its predicate K020208.

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 ELITE Blood Glucose Meter is used with Ascensia ELITE Blood Glucose Test Strips, and Ascensia ELITE Controls for the measurement of glucose in whole blood from specimens taken from the fingers or an alternate puncture site within certain conditions. The Ascensia ELITE Diabetes Care 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 frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

Indications for use as stated in the FDA summary.

Also cleared against K020208

2 other devices cite the same predicate.

  • K042795Clever Chek TD-3213Taidoc Technology Corporation · 2005
  • K041107Taidoc CheckTaidoc Technology Corporation · 2004

More from Bayer Healthcare, LLC

50 FDA decisions under this applicant name. See the company

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  • K152852ALEVE Direct Therapy (ALEVE Direct Therapy TENS device)Bayer Healthcare, LLC · 2015
  • K130265Contour Next EZ Blood Glucose MeterBayer Healthcare, LLC · 2014
  • K121190Contour Next Blood Glucose MeterBayer Healthcare, LLC · 2012
  • K110587Contour Link Blood Glucose Meter, Contour Blood Glucose Test Strips, Contour Control Solution (High, Normal…Bayer Healthcare, LLC · 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/K043311 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043311: Ascensia Elite Diabetes Care System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043311

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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