510(k) Report

510(k) · Cleared

Cleared

MyGlucoHealth Wireless System

K143169510(k) SpecialCleared Jan 8, 2016430-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

Entra Health Systems · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Jan 8, 2016 as substantially equivalent to K081703 (Entra Health Systems, Ltd., 2009) after a 430-day review. Its family tree reaches back 4 generations to 1995.

Decided
Jan 8, 2016
Review
430 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K950727 (1995). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2000: 1 other ancestorK950727 · One Touch Profile Complete Diabetes Tracking System · Lifescan, Inc. · 1995K021819 · One Touch Ultrasmart Blood Glucose Monitoring System · Lifescan, Inc. · 2002 · recalledK072369 · Evolution Blood Glucose Monitoring System · Hmd Biomedical, LLC · 2008K081703 · Myglucohealth Glucose Monitoring Systems · Entra Health Systems, Ltd. · 200919952000200520102015
Other ancestors, by generation 4 generations back: 1 other ancestor K081703 · Myglucohealth Glucose Monitoring Systems · Entra Health Systems, Ltd. · 2009K072369 · Evolution Blood Glucose Monitoring System · Hmd Biomedical, LLC · 2008K021819 · One Touch Ultrasmart Blood Glucose Monitoring System · Lifescan, Inc. · 2002 · recalledK950727 · One Touch Profile Complete Diabetes Tracking System · Lifescan, Inc. · 19950
  1. Root · 4 generations backK950727 One Touch Profile Complete Diabetes Tracking SystemLifescan, Inc. · 1995
  2. 3 generations backK021819 One Touch Ultrasmart Blood Glucose Monitoring SystemLifescan, Inc. · 2002 · Recalled
  3. 2 generations backK072369 Evolution Blood Glucose Monitoring SystemHmd Biomedical, LLC · 2008
  4. 1 generation backK081703 Myglucohealth Glucose Monitoring SystemsEntra Health Systems, Ltd. · 2009
  5. This deviceK143169 MyGlucoHealth Wireless SystemEntra Health Systems · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K950727One Touch Profile Complete Diabetes Tracking SystemLifescan, Inc.1995—
−3K021819One Touch Ultrasmart Blood Glucose Monitoring SystemLifescan, Inc.20021
−2K072369Evolution Blood Glucose Monitoring SystemHmd Biomedical, LLC2008—
−1K081703Myglucohealth Glucose Monitoring SystemsEntra Health Systems, Ltd.2009—
0 (this device)K143169MyGlucoHealth Wireless SystemEntra Health Systems2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
FIG. 1 — Lineage of K143169, 1995–2016Source: 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
*K081703Myglucohealth Glucose Monitoring Systems
Summary page 4
…ice(s): MyGlucoHealth Glucose Monitoring System, Model MGH-BT1, Entra Health Systems (K081703) H. Common Name: Glucose Test System I. Classification: Class II Regulation…
Entra Health Systems, Ltd.2009—

Also cleared against K081703: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 21 years and passes through 4 companies; a new generation was cleared every 7.0 years on median.
  • 1 of the 5 ancestors has a recall of any class.
  • 1 other device also cites its predicate K081703.

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. 2016, 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 MyGlucoHealth Wireless System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of glucose control. The system is comprised of the MyGlucoHealth Wireless Meter, MyGlucoHealth Control Solutions and MyGlucoHealth Wireless Test Strip. The system is intended to be used for the quantitative measurement of glucose (sugar) in whole blood samples drawn from the…

Read the full statement (132 words)

The MyGlucoHealth Wireless System is intended for self-testing outside the body (in vitro diagnostic use) by people with

diabetes at home as an aid to monitor the effectiveness of glucose control. The system is comprised of the MyGlucoHealth

Wireless Meter, MyGlucoHealth Control Solutions and MyGlucoHealth Wireless Test Strip. The system is intended to be

used for the quantitative measurement of glucose (sugar) in whole blood samples drawn from the fingertip, ventral palm,

hand,upper arm, forearm, calf and/or thigh. The MyGlucoHealth Wireless Meter is intended to be used by a single patient

and should not be shared. The MyGlucoHealth Wireless System is not to be used for the diagnosis of or screening for

diabetes or for neonatal use. Alternate site testing should be done during steady-state times (when glucose is not changing

rapidly).

Indications for use as stated in the FDA summary.

Also cleared against K081703

1 other device cites the same predicate.

  • K113105Tempusic Patient MonitorRemote Diagnostic Technologies, Ltd. · 2011

More from Entra Health Systems

2 FDA decisions under this applicant name. See the company

  • K132930Myhealthpoint Telehealth ManagerEntra Health Systems · 2014

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/K143169 · printed Nov 4, 2026

Cite this page

510(k) Report. “K143169: MyGlucoHealth Wireless System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143169

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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