510(k) · Cleared
ClearedMedisign 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 Feb 28, 2012 as substantially equivalent to K053529 (Lifescan, Inc., 2006) and 1 other predicate after a 279-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Feb 28, 2012
- Review
- 279 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000318 (2000). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK000318 Bionostics Glucose Quality Control Solution for Use with the…Bionostics, Inc. · 2000
- 1 generation backK022769 Lifescan Onetouch Ultra Control SolutionBionostics, Inc. · 2002
- This deviceK111456 Medisign Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK152534 Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100…Tianjin Empecs Medical Device Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK133260 Medisign Blood Glucse Monitoring System, Medisign Multi Blood…Tianjin Empecs Medical Device Co., Ltd. · 2014
Most influential descendants
Showing 2 of 2 · See all- K152534Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose…Tianjin Empecs Medical Device Co., Ltd. · 2017 · cites it directly0descendants
- K133260Medisign Blood Glucse Monitoring System, Medisign Multi Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000318 | Bionostics Glucose Quality Control Solution for Use with the Fasttake Compact… | Bionostics, Inc. | 2000 | — |
| −1 | K022769 | Lifescan Onetouch Ultra Control Solution | Bionostics, Inc. | 2002 | — |
| 0 (this device) | K111456 | Medisign Blood Glucose Monitoring System | Tianjin Empecs Medical Device Co., Ltd. | 2012 | — |
| +1 | K152534 | Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood… | Tianjin Empecs Medical Device Co., Ltd. | 2017 | — |
| +1 | K133260 | Medisign Blood Glucse Monitoring System, Medisign Multi Blood Glucose… | Tianjin Empecs Medical Device Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K053529 | Onetouch Ultra 2 Blood Glucose Monitoring SystemSummary page 1…s 1,21 CFR 862.1660, Quality Control Material Produce code: NBW, CGA and lix Predicate Devices: OneTouch Ultra 2 Blood Glucose Monitoring System (K053529) OneTouch Ultra Control Solution (K022769) Device Description: Medisign MM 1000 Blood Glucose Monito… | 2006 |
| * | K022769 | Lifescan Onetouch Ultra Control SolutionSummary page 1…NBW, CGA and lix Predicate Devices: OneTouch Ultra 2 Blood Glucose Monitoring System (K053529) OneTouch Ultra Control Solution (K022769) Device Description: Medisign MM 1000 Blood Glucose Monitoring System, Medisign MMI 100 Blood Glucose Monitoring System, and Med… | 2002 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 2 companies; a new generation was cleared every 9.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K152534 (Tianjin Empecs Medical Device Co., Ltd., 2017) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K053529.
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. 2012, 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 system is intended for the quantitative measurement of the concentration of glucose in whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes, is intended for self-testing by persons at home, is for single-patient use only, and should not be shared. It is intended for use the outside of body (in vitro diagnostic use) and not for diagnosis of or screening for diabetes, nor for use on…
Read the full statement (1,483 words)
The system is intended for the quantitative measurement of the concentration of glucose in whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes, is intended for self-testing by persons at home, is for single-patient use only, and should not be shared. It is intended for use the outside of body (in vitro diagnostic use) and not for diagnosis of or screening for diabetes, nor for use on neonates.
The alternative site testing (palm and forearm) in this system can only be used during stead-state blood glucose conditions.
The Medisign- MMIOOO test strip is to be used with Medisign-'MMl000 Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign" MM 1000 test strips and associated meter are for use in fingertip, forearm, and palm testing. The strips are intended for self-testing by persons at home, are for single-patient use only, and should not be shared. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.
Medisign T m Glucose Control Solutions are for use with Medisign Tm Brand Blood Glucose Meters and MedisignIN Test Strips to check that the meter and test strips are working together properly.
Medisign' Glucose Control Solutions are intended for use by healthcare professionals and people with diabetes mellitus at home, MesisignJN Glucose Control Solutions are for in vitro diagnostic use.
The system is intended for the quantitative measurement of the concentration of glucose in whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes, is intended for self-testing by persons at home, is for single-patient use only, and should not be shared. It is intended for use the outside of body (in vitro diagnostic use) and not for diagnosis of or screening for diabetes, nor for use on neonates.
The alternative site testing (palm and forearm) in this system can only be used during stead-state blood glucose conditions.
The Medisignm MMlIOO test strip is to be used with Medisign- MMlIOO Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign- MMII0O test strips and associated meter are for use in fingertip, forearm, and palmn testing. The strips are intended for self-testing by persons at home, are for single-patient use only, and should not be shared. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.
Medlisign m ' Glucose Control Solutions are for use with Medisig" Brand Blood Glucose Meters and Medisign Test Strips to check that the meter and test strips are working together properly.
MedisignT m Glucose Control Solutions are intended for use by healthcare professionals and people with diabetes mellitus at home, Mesisign m Glucose Control Solutions are for in vitro diagnostic use.
The system is intended for the quantitative measurement of the concentration of glucose in whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the management of diabetes, is intended for self-testing by persons at home, is for single-patient use only, and should not be shared. It is intended for use the outside of body (in vitro diagnostic use) and not for diagnosis of or screening for diabetes, nor for use on neonates.
The alternative site testing (palm and forearm) in this system can only be used during stead-state blood glucose conditions.
The Medisign- MM 1200 test strip is to be used with Medisignm MM 1200 Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisigiw' MM 1200, test strips and associated meter are for use in fingertip, forearm, and palm testing. The strips are intended for self-testing by persons at home, are for single-patient use only, and should not be shared. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.
Medisign m Glucose Control Solutions are for use with Medisign~v Brand Blood Glucose Meters and Medisign TM Test Strips to check that the meter and test strips are working together properly.
Medisign T m Glucose Control Solutions are intended for use by healthcare professionals and people with diabetes mellitus at home, Mesisign~N Glucose Control Solutions are for in vitro diagnostic use.
The system is intended for the quantitative measurement of the concentration of glucose in whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes and may be used for testing multiple patients in professional healthcare settings. It is intended for use the outside of body (in vitro diagnostic use) and not for diagnosis of or screening for diabetes, nor for use on neonates.
The alternative site testing (palm and forearm) in this system can only be used during stead-state blood glucose conditions. Only auto-disabling, single use lancing device should be used with this system.
The Medisign-' MMIOOO Multi Blood Glucose Test strip is to be used with Medisignm, MM1000 Multi Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisignm MIOOO00 Multi Test strips and associated meters are for use in fingertip, forearm, and palm testing. The system is intended for use for multiple-patient use by healthcare professionals in healthcare settings. Only auto-disabling, single use lancing devices should be used with this system to prevent transferring disease by blood. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.
Medisign~m Glucose Control Solutions are for use with Medisign~m Brand Blood Glucose Meters and Medisign " Test Strips to check that the meter and test strips are working together properly.
Medisign~m Glucose Control Solutions are intended for use by healthcare professionals and people with diabetes mellitus at home. Mesisign1 N Glucose Control Solutions are for in vitro diagnostic use.
The system is intended for the quantitative measurement of the concentration of glucose in whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes and may be used for testing multiple patients in professional healthcare settings. It is intended for use the outside of body (in vitro diagnostic use) and not for diagnosis of or screening for diabetes, nor for use on neonates.
The alternative site testing (palm and forearm) in this system can only be used during stead-state blood glucose conditions. Only auto-disabling, single use lancing device should be used with this system.
The Medisign"- MM 1100 Multi Blood Glucose Test strip is to be used with Medisign-' MMI 100 Multi Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign-MMII100 Multi Test strips and associated meters are for use in fingertip, forearm, and palm testing. The system is intended for use for multiple-patient use by healthcare professionals in healthcare settings. Only auto-disabling, single use lancing devices should be used with this system to prevent transferring disease by blood. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.
Medisign m Glucose Control Solutions are for use with Medisign' m Brand Blood Glucose Meters and MedisignI m Test Strips to check that the meter and test strips are working together properly.
Medisign m Glucose Control Solutions are intended for use by healthcare professionals and people with diabetes mellitus at home. Mesisign'm Glucose Control Solutions are for in vitro diagnostic use.
The system is intended for the quantitative measurement of the concentration of glucose in whole blood drawn from fingertip, palm, and forearm of diabetic patients by healthcare professionals as an aid in the management of diabetes and may be used for testing multiple patients in professional healthcare settings. It is intended for use the outside of body (in vitro diagnostic use) and not for diagnosis of or screening for diabetes, nor for use on neonates.
The alternative site testing (palm and forearm) in this systemi can only be used during stead-state blood glucose conditions. Only auto-disabling, single use lancing device should be used with this system.
The MedisignM MMv1200 Multi Blood Glucose Test strip is to be used with Medisignm MM 1200 Multi Blood Glucose Meter, to monitor glucose concentration of capillary whole blood. Medisign"' MM1200 Multi Test strips and associated meters are for use in fingertip, forearm, and palm testing. The system is intended for use for multiple-patient use by healthcare professionals in healthcare settings. Only auto-disabling, single use lancing devices should be used with this system to prevent transferring disease by blood. The strips are not for diagnosis of or screening for diabetes nor for neonatal use.
Medisign T m Glucose Control Solutions are for use with Medisignm Brand Blood Glucose Meters and Medisig1Y'm Test Strips to check that the meter and test strips are working together properly.
Medisign m Glucose Control Solutions are intended for use by healthcare professionals and people with diabetes mellitus at home. Mvesisign' Glucose Control Solutions are for in vitro diagnostic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111456 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111456: Medisign Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111456
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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