510(k) Report

510(k) · Cleared

Cleared

MCT-Diabetes

K073699510(k) TraditionalCleared Mar 26, 200886-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

Mycare Team, Inc. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Mar 26, 2008 as substantially equivalent to K070593 (Home Diagnostics, Inc., 2007) after an 86-day review. Its family tree reaches back 1 generation to 2007. 7 later devices descend from it.

Decided
Mar 26, 2008
Review
86 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K070593 (2007). 7 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2010: 1 descendant cleared2011: 3 descendants cleared2012: 1 descendant cleared2014: 1 descendant clearedK070593 · Trackrecord Data Management Software · Home Diagnostics, Inc. · 200720052010201520202025
Descendants, by generation 1 generation forward: 5 descendants2 generations forward: 1 descendant3 generations forward: 1 descendant K070593 · Trackrecord Data Management Software · Home Diagnostics, Inc. · 20070
  1. Root · 1 generation backK070593 Trackrecord Data Management SoftwareHome Diagnostics, Inc. · 2007
  2. This deviceK073699 MCT-DiabetesMycare Team, Inc. · 2008
  3. Descendant · cites it directly · 2 of its ownK110571 Telcare Blood Glucose Monitoring System, Test Strips, Control…Telcare, Inc. · 2011 · Recalled
  4. Descendant · 2 generations on · 1 of its ownK120064 Test, Blood Glucose SystemHmd Biomedical, Inc. · 2012
  5. Descendant · cites it directly · 1 of its ownK083263 Symcare Diabetes Management ProgramSymcare Personalized Health Solutions, Inc. · 2009
  6. Descendant · 3 generations on · 0 of its ownK131173 FIA Blood Glucose Monitoring System (G2)Hmd Biomedical, Inc. · 2014
  7. Descendant · cites it directly · 0 of its ownK111509 Sweetspot Diabetes Data Management ServiceSweetspot Diabetes Care, Inc. · 2011

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12011: 32012: 12014: 1
2009high 3 (2011) · low 0 (2013)2026

Most influential descendants

Showing 5 of 7 · See all
  • K110571Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions, Telserve-Home…Telcare, Inc. · 2011 · cites it directly2descendants
  • K120064Test, Blood Glucose SystemHmd Biomedical, Inc. · 2012 · 2 generations on1descendant
  • K083263Symcare Diabetes Management ProgramSymcare Personalized Health Solutions, Inc. · 2009 · cites it directly1descendant
  • K131173FIA Blood Glucose Monitoring System (G2)Hmd Biomedical, Inc. · 2014 · 3 generations on0descendants
  • K111509Sweetspot Diabetes Data Management ServiceSweetspot Diabetes Care, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K070593Trackrecord Data Management SoftwareHome Diagnostics, Inc.2007—
0 (this device)K073699MCT-DiabetesMycare Team, Inc.2008—
+1K110571Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions…Telcare, Inc.20111
+2K120064Test, Blood Glucose SystemHmd Biomedical, Inc.2012—
+1K083263Symcare Diabetes Management ProgramSymcare Personalized Health Solutions, Inc.2009—
+3K131173FIA Blood Glucose Monitoring System (G2)Hmd Biomedical, Inc.2014—
+1K111509Sweetspot Diabetes Data Management ServiceSweetspot Diabetes Care, Inc.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201130
201210
201410
FIG. 1 — Lineage of K073699, 2007–2014Source: 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
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.

TypeNumberDeviceApplicantDecidedRecalls
*K070593Trackrecord Data Management Software
Summary page 1
…(508) 347-0242 Date Prepared: December 31, 2007 A. LEGALLY MARKETED PREDICATE DEVICE Name of Predicate: K070593, TrackRecord Data Management Software, Home Diagnostics Inc. Product Code, Class No. 1: NBW, C…
Home Diagnostics, Inc.2007—

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K110571Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions, Telserve-Home…Telcare, Inc.20112
K083263Symcare Diabetes Management ProgramSymcare Personalized Health Solutions, Inc.20091
K111509Sweetspot Diabetes Data Management ServiceSweetspot Diabetes Care, Inc.20110
K110709Ark Care Diabetes Managment SystemArkray Factory USA, Inc.20110
K093789Intouch DiabetesSymcare Personalized Health Solutions, Inc.20100

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, K110571 (Telcare, Inc., 2011) has gone furthest, with 2 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. 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 MCT-DiabetesTM software serves as an interface between the software in personal glucose monitoring devices and a general purpose health management database to assist in the review, analysis and evaluation of blood glucose test results. MCT Diabetes is designed for home use and professional healthcare settings.

Indications for use as stated in the FDA summary.

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/K073699 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073699: MCT-Diabetes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073699

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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