510(k) Report

510(k) · Cleared

Cleared

Ascensia Glucofacts; Ascensia Glucofacts Professional

K024234510(k) TraditionalCleared Jan 23, 200331-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 Corp. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Jan 23, 2003 as substantially equivalent to K861844 (Miles Laboratories, Inc., 1986) after a 31-day review. Its family tree reaches back 1 generation to 1986. 6 later devices descend from it.

Decided
Jan 23, 2003
Review
31 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K861844 (1986). 6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2012: 1 descendant cleared2010: 1 descendant cleared2013: 2 descendants cleared2014: 1 descendant clearedK861844 · Glucofacts Data Management System · Miles Laboratories, Inc. · 19861990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 2 descendants K861844 · Glucofacts Data Management System · Miles Laboratories, Inc. · 19860
  1. Root · 1 generation backK861844 Glucofacts Data Management SystemMiles Laboratories, Inc. · 1986
  2. This deviceK024234 Ascensia Glucofacts; Ascensia Glucofacts ProfessionalBayer Corp. · 2003
  3. Descendant · cites it directly · 5 of its ownK082486 Glucofacts Express Diabetes Management SoftwareBayer Healthcare, LLC · 2008
  4. Descendant · 2 generations on · 3 of its ownK122142 Glooko Logbook ChartsGlooko, Inc. · 2012
  5. Descendant · 3 generations on · 2 of its ownK130886 Glooko Device System for Glooko Logbook+ ApplicationGlooko, Inc. · 2013
  6. Descendant · 4 generations on · 0 of its ownK141862 HEALTH2SYNC Mobile Application, HEALTH2SYNC Smart CableH2, Inc. · 2014
  7. Descendant · 4 generations on · 0 of its ownK132272 Glooko Device System for Glooko ApplicationGlooko, Inc. · 2013

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2008: 12010: 12012: 12013: 22014: 1
2008high 2 (2013) · low 0 (2009)2026

Most influential descendants

Showing 5 of 6 · See all
  • K082486Glucofacts Express Diabetes Management SoftwareBayer Healthcare, LLC · 2008 · cites it directly5descendants
  • K122142Glooko Logbook ChartsGlooko, Inc. · 2012 · 2 generations on3descendants
  • K130886Glooko Device System for Glooko Logbook+ ApplicationGlooko, Inc. · 2013 · 3 generations on2descendants
  • K141862HEALTH2SYNC Mobile Application, HEALTH2SYNC Smart CableH2, Inc. · 2014 · 4 generations on0descendants
  • K132272Glooko Device System for Glooko ApplicationGlooko, Inc. · 2013 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K861844Glucofacts Data Management SystemMiles Laboratories, Inc.1986—
0 (this device)K024234Ascensia Glucofacts; Ascensia Glucofacts ProfessionalBayer Corp.2003—
+1K082486Glucofacts Express Diabetes Management SoftwareBayer Healthcare, LLC2008—
+2K122142Glooko Logbook ChartsGlooko, Inc.2012—
+3K130886Glooko Device System for Glooko Logbook+ ApplicationGlooko, Inc.2013—
+4K141862HEALTH2SYNC Mobile Application, HEALTH2SYNC Smart CableH2, Inc.2014—
+4K132272Glooko Device System for Glooko ApplicationGlooko, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201010
201210
201320
201410
FIG. 1 — Lineage of K024234, 1986–2014Source: 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
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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
*K861844Glucofacts Data Management System
Summary page 1
…anagement System Manufacturer: Bayer Diagnostics 430 S. Bieger Street Mishawaka, In 46544 5 1O(k) Number: K86 1844 Device Description The Ascensia w'"Glucofacts and the Ascensia w'"Glucofacts Professional s o h a r e consist of a CD, and a co…
Miles Laboratories, Inc.1986—

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K082486Glucofacts Express Diabetes Management SoftwareBayer Healthcare, LLC20085

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?

  • Its one ancestor has no recall.
  • Of its descendants, K082486 (Bayer Healthcare, LLC, 2008) has gone furthest, with 5 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 wmGlucofacts and the Ascensia Win Glucofacts Professional software are accessories to the Ascensiam Blood Glucose monitoring systems. The Ascensia winGlucofacts and the Ascensia w"Glucofacts Professional software are Over-The Counter (OTC) devices used by persons with diabetes and by healthcare professionals for data transfer in the home and in healthcare facilities.

Indications for use as stated in the FDA summary.

More from Bayer Corp.

96 FDA decisions under this applicant name. See the company

  • K024062Ascensia Breeze Blood Glucose MeterBayer Corp. · 2003
  • K023944Bayer Diagnostics Clinitest Pregnancy TestBayer Corp. · 2003
  • K024017Bayer Advia Centaur Her-2/Neu AssayBayer Corp. · 20031 recall
  • K022288Complexed Prostate Specific Antigen (Cpsa) Assay for the Bayer Advia Integrated Module SystemBayer Corp. · 2002
  • K023584Ascensia Dex 2 Diabetes Care SystemBayer Corp. · 2002

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/K024234 · printed Nov 6, 2026

Cite this page

510(k) Report. “K024234: Ascensia Glucofacts; Ascensia Glucofacts Professional.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024234

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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