510(k) · Cleared
ClearedMedisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tianjin Empecs Medical Device Co., Ltd. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jun 7, 2017 as substantially equivalent to K150214 (Lifescan Europe, 2015) after a 266-day review. Its family tree reaches back 5 generations to 2006.
- Decided
- Jun 7, 2017
- Review
- 266 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K053529 (2006). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK053529 Onetouch Ultra 2 Blood Glucose Monitoring SystemLifescan, Inc. · 2006
- 4 generations backK093745 One Touch Verio Blood Glucose Monitoring SystemLifescan, Inc. · 2011
- 3 generations backK110637 Onetouch Verio (TM) IQ Blood Glucose Monitoring SystemCilag GmbH International · 2011 · Recalled
- 2 generations backK131363 Onetouch Verio Blood Glucose Monitoring SystemCilag GmbH International · 2013
- 1 generation backK150214 OneTouch Verio Flex Blood Glucose Monitoring SystemLifescan Europe · 2015
- This deviceK162564 Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood…Tianjin Empecs Medical Device Co., Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K053529 | Onetouch Ultra 2 Blood Glucose Monitoring System | Lifescan, Inc. | 2006 | — |
| −4 | K093745 | One Touch Verio Blood Glucose Monitoring System | Lifescan, Inc. | 2011 | — |
| −3 | K110637 | Onetouch Verio (TM) IQ Blood Glucose Monitoring System | Cilag GmbH International | 2011 | 1 |
| −2 | K131363 | Onetouch Verio Blood Glucose Monitoring System | Cilag GmbH International | 2013 | — |
| −1 | K150214 | OneTouch Verio Flex Blood Glucose Monitoring System | Lifescan Europe | 2015 | — |
| 0 (this device) | K162564 | Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose… | Tianjin Empecs Medical Device Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K150214 | OneTouch Verio Flex Blood Glucose Monitoring SystemSummary page 10…75-Chemistry test system 10. Predicate Device Information Device Name: OneTouch Verio Flex Blood Glucose Monitoring System 510(k) Number: k150214 11. Indications for Use Medisign®GH81 Blood Glucose Monitoring System The Medisign GH81 Blood Glucose Monitoring Syste… | 2015 |
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 11 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K150214.
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. 2017, 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?
The Medisign GH81 Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (in-vitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for…
Read the full statement (783 words)
The Medisign GH81 Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (in-vitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steady-state times (when glucose is not changing rapidly).
The Medisign GH81 Blood Glucose Monitoring System is comprised of the Medisign GH81 Blood Glucose Meter and Medisign GH81 Blood Glucose Test Strips.
The Medisign GH82 Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (in-vitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steady-state times (when glucose is not changing rapidly).
The Medisign GH82 Blood Glucose Monitoring System is comprised of the Medisign GH82 Blood Glucose Meter and Medisign GH82 Blood Glucose Test Strips.
The Medisign GH83 Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (in-vitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steady-state times (when glucose is not changing rapidly).
The Medisign GH83 Blood Glucose Monitoring System is comprised of the Medisign GH83 Blood Glucose Meter and Medisign GH83 Blood Glucose Test Strips.
The Medisign GH81 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (in-vitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steady-state times (when glucose is not changing rapidly).
The Medisign GH81 BT Blood Glucose Monitoring System is comprised of the Medisign GH81 BT Blood Glucose Meter and Medisign GH81 Blood Glucose Test Strips.
The Medisign GH82 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (in-vitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steady-state times (when glucose is not changing rapidly).
The Medisign GH82 BT Blood Glucose Monitoring System is comprised of the Medisign GH82 BT Blood Glucose Meter and Medisign GH82 Blood Glucose Test Strips.
The Medisign GH83 BT Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose in fresh capillary whole blood drawn from fingertip, palm and forearm. It is intended for self-testing outside the body (in-vitro diagnostics use only) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended for single patient use only and should not be shared. It is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. Alternative site testing (palm and forearm) should be done only during steady-state times (when glucose is not changing rapidly).
The Medisign GH83 BT Blood Glucose Monitoring System is comprised of the Medisign GH83 BT Blood Glucose Meter and Medisign GH83 Blood Glucose Test Strips.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162564 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162564: Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83 Blood Glucose Monitoring System, Medisign GH81 BT Blood Glucose Monitoring System, Medisign GH82 BT Blood Glucose Monitoring System, Medisign GH83 BT Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162564
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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