510(k) · Cleared
Recalled · Class II · 2025Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions, Telserve-Home Use, Telserve-Professional Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Telcare, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jul 28, 2011 as substantially equivalent to K102037 (Apex BioTechnology Corp., 2010) and 2 other predicates after a 149-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it. It has been recalled once.
- Decided
- Jul 28, 2011
- Review
- 149 days
- Class
- Class II
- Product code
- NBW
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K011233 (2001). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK011233 Modification to Glucosure BGM System, Model 221100Apex BioTechnology Corp. · 2001 · Recalled
- 1 generation backK062799 Gluco Track Blood Glucose Monitoring SystemApex BioTechnology Corp. · 2007
- This deviceK110571 Telcare Blood Glucose Monitoring System, Test Strips, Control…Telcare, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK120064 Test, Blood Glucose SystemHmd Biomedical, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK131173 FIA Blood Glucose Monitoring System (G2)Hmd Biomedical, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011233 | Modification to Glucosure BGM System, Model 221100 | Apex BioTechnology Corp. | 2001 | 1 |
| −1 | K062799 | Gluco Track Blood Glucose Monitoring System | Apex BioTechnology Corp. | 2007 | — |
| 0 (this device) | K110571 | Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions… | Telcare, Inc. | 2011 | — |
| +1 | K120064 | Test, Blood Glucose System | Hmd Biomedical, Inc. | 2012 | — |
| +2 | K131173 | FIA Blood Glucose Monitoring System (G2) | Hmd Biomedical, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
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 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K102037 | Autosure Voice II Blood Glucose Monitoring System and Test StripsSummary page 1…glucose monitoring system) Exemp Product Codes: NBW, CGA, JJX, JQP Predicate AutoSure Voice II Blood Glucose Monitoring System (BGM) - k102037, Devices: MCT-Diabetes (Data Management Software) - k073699, Gluco Track Blood Glucose Monitoring Syst… | 2010 |
| * | K073699 | MCT-DiabetesSummary page 1…s: NBW, CGA, JJX, JQP Predicate AutoSure Voice II Blood Glucose Monitoring System (BGM) - k102037, Devices: MCT-Diabetes (Data Management Software) - k073699, Gluco Track Blood Glucose Monitoring System (control solutions) - k062799 Device The Telcare Blood… | 2008 |
| * | K062799 | Gluco Track Blood Glucose Monitoring SystemSummary page 1…(BGM) - k102037, Devices: MCT-Diabetes (Data Management Software) - k073699, Gluco Track Blood Glucose Monitoring System (control solutions) - k062799 Device The Telcare Blood Glucose Monitoring System consists of the Telcare Blood Description: Glucose Meter (BOM)… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120064 | Test, Blood Glucose System | 2012 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 30, 2025 | Class II | Z-1270-2025 | Software design | Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips Connected Blood Glucose Meter (i.e., BGM 4 brand name) Monitoring System.. The issue was identified by post market surveillance data… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K120064 (Hmd Biomedical, Inc., 2012) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K102037.
How does its category compare?
All NBW devicesNBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NBW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBW
243in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBW
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NBW
4,745in 2025
MAUDE reports naming product code NBW, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 29 | 85 | 9 | 7,991 |
| 2008 | 37 | 128 | 2 | 7,704 |
| 2009 | 38 | 140 | 5 | 10,963 |
| 2010 | 31 | 132 | 11 | 11,631 |
| 2011 | 30 | 328 | 1 | 22,909 |
| 2012 | 30 | 230 | 1 | 23,449 |
| 2013 | 47 | 167 | 5 (2) | 35,408 |
| 2014 | 24 | 202 | 1 | 38,524 |
| 2015 | 32 | 237 | 0 | 62,111 |
| 2016 | 20 | 233 | 1 | 76,621 |
| 2017 | 25 | 244 | 0 | 37,538 |
| 2018 | 19 | 168 | 0 | 16,911 |
| 2019 | 10 | 127 | 14 | 14,472 |
| 2020 | 7 | 121 | 0 | 10,703 |
| 2021 | 7 | 465 | 0 | 9,198 |
| 2022 | 12 | 410 | 0 | 8,103 |
| 2023 | 5 | 193 | 0 | 7,256 |
| 2024 | 7 | 243 | 0 | 6,220 |
| 2025 | 2 | — | 1 | 4,745 |
| 2026 | 5 | 190 | 0 | — |
What is it indicated for?
Telcare Blood Glucose Monitoring System The Telcare Blood Glucose Monitoring system is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended for lay use by persons with diabetes to aid in diabetes management. It is indicated for use at home (over the counter [OTC]) and should be used only by a single patient and should not be shared. Testing is done outside…
Read the full statement (476 words)
Telcare Blood Glucose Monitoring System
The Telcare Blood Glucose Monitoring system is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended for lay use by persons with diabetes to aid in diabetes management. It is indicated for use at home (over the counter [OTC]) and should be used only by a single patient and should not be shared. Testing is done outside the body (in vitro diagnostic use). The Telcare Blood Glucose Monitoring System consists of the Telcare Blood Glucose Meter, Telcare Blood Glucose Test Strips, and Telcare Glucose Control Solutions. The Telcare Blood Glucose Monitoring system is not indicated for the diagnosis or screening of diabetes or for neonatal use. Palm and forearm testing should be done only during steady-state times when glucose is not changing rapidly. The Telcare Blood Glucose Meter uses cellular data transmission to send test results to Telcare's remote database,Telserve, and to receive messages from Telserve. The Telcare Blood Glucose Monitoring System is not intended to provide automated treatment guidance or decisions, nor is it to be used as a substitute for professional healthcare judgment.
Telcare Blood Glucose Test Strips
The Telcare Blood Glucose Test Strips are to be used with the Telcare Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, palm, or forearm. These test strips are intended for lay use by persons with diabetes and should only be used by a single patient. They are not indicated for the diagnosis or screening of diabetes or for neonatal use. Palm and forearm testing should be done only during steady-state times when glucose is not changing rapidly.
Telcare Glucose Control Solutions
The purpose of the control solution is to validate the performance of the Telcare Blood Glucose Monitoring System by using a test solution with a known amount of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.
Telserve Data Management System - Home Use
The Telserve Data Management System - Home Use (Telserve - Home) is an accessory to blood glucose monitoring systems for the review and evaluation of blood glucose test results to aid in diabetes management. Telserve collects data from blood glucose meters such as the Telcare BGM. Telserve - Home is not intended to provide automated treatment guidance or decisions, nor is it to be used as a substitute for professional healthcare judgment.
Telserve Data Management System - Professional Use
The Telserve Data Management System - Professional Use (Telserve - Pro) is an accessory to blood glucose monitoring systems for the review and evaluation of blood glucose test results to aid in diabetes management. Telserve collects data from blood glucose meters such as the Telcare BGM.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110571 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110571: Telcare Blood Glucose Monitoring System, Test Strips, Control Solutions, Telserve-Home Use, Telserve-Professional Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110571
Report an extraction error
Are you the manufacturer?
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