510(k) Report

510(k) · Cleared

Cleared

Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System

K152534510(k) SpecialCleared Mar 21, 2017564-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

Tianjin Empecs Medical Device Co., Ltd. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Mar 21, 2017 as substantially equivalent to K111456 (Tianjin Empecs Medical Device Co., Ltd., 2012) after a 564-day review. Its family tree reaches back 3 generations to 2000.

Decided
Mar 21, 2017
Review
564 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K000318 (2000). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestorK000318 · Bionostics Glucose Quality Control Solution for Use with the Fasttake Compact Blood Glucose Monitoring System · Bionostics, Inc. · 2000K022769 · Lifescan Onetouch Ultra Control Solution · Bionostics, Inc. · 2002K111456 · Medisign Blood Glucose Monitoring System · Tianjin Empecs Medical Device Co., Ltd. · 20122000200520102015
Other ancestors, by generation 2 generations back: 1 other ancestor K111456 · Medisign Blood Glucose Monitoring System · Tianjin Empecs Medical Device Co., Ltd. · 2012K022769 · Lifescan Onetouch Ultra Control Solution · Bionostics, Inc. · 2002K000318 · Bionostics Glucose Quality Control Solution for Use with the Fasttake Compact Blood Glucose Monitoring System · Bionostics, Inc. · 20000
  1. Root · 3 generations backK000318 Bionostics Glucose Quality Control Solution for Use with the…Bionostics, Inc. · 2000
  2. 2 generations backK022769 Lifescan Onetouch Ultra Control SolutionBionostics, Inc. · 2002
  3. 1 generation backK111456 Medisign Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd. · 2012
  4. This deviceK152534 Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100…Tianjin Empecs Medical Device Co., Ltd. · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K000318Bionostics Glucose Quality Control Solution for Use with the Fasttake Compact…Bionostics, Inc.2000—
−2K022769Lifescan Onetouch Ultra Control SolutionBionostics, Inc.2002—
−1K111456Medisign Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd.2012—
0 (this device)K152534Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood…Tianjin Empecs Medical Device Co., Ltd.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200610
FIG. 1 — Lineage of K152534, 2000–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K111456Medisign Blood Glucose Monitoring System
Summary page 11
…Class I, 21 CFR 862.1660, Quality Control Material Product code: NBW, CGA and JJX 3. Predicate Device Information: K111456 Medisign® Blood Glucose Monitoring System 4. Device Description:…
Tianjin Empecs Medical Device Co., Ltd.2012—

Also cleared against K111456: 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 17 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
  • None of the 4 ancestors has a recall.
  • 1 other device also cites its predicate K111456.

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. 2017, 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?

Medisign MM1000 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 by a single patient (lay user) as an aid in the management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be shared. It is intended for use outside the body (in-vitro diagnostic use only) and not for the diagnosis…

Read the full statement (1,635 words)

Medisign MM1000 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 by a single patient (lay user) as an aid in the

management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be

shared. It is intended for use outside the body (in-vitro diagnostic use only) and not for the diagnosis of or screening for

diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times

(when glucose is not changing rapidly).

The Medisign MM1000 Blood Glucose Test Strips are to be used for monitoring glucose concentration

of fresh capillary whole blood with Medisign MM1000 BT Blood Glucose Meter. The test strips and associated meters are

for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home, are for

single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or

for neonatal use.

Medisign MM1100 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 by a single patient (lay user) as an aid in the

management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be

shared. It is intended for use outside the body (in-vitro diagnostic use only) and not for the diagnosis of or screening for

diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times

(when glucose is not changing rapidly).

The Medisign MM1100 Blood Glucose Test Strips are to be used for monitoring glucose concentration

of fresh capillary whole blood with Medisign MM1100 BT Blood Glucose Meter. The test strips and associated meters are

for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home, are for

single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or

for neonatal use.

Medisign MM1200 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 by a single patient (lay user) as an aid in the

management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be

shared. It is intended for use outside the body (in-vitro diagnostic use only) and not for the diagnosis of or screening for

diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times

(when glucose is not changing rapidly).

The Medisign MM1200 Blood Glucose Test Strips are to be used for monitoring glucose concentration

of fresh capillary whole blood with Medisign MM1200 BT Blood Glucose Meter. The test strips and associated meters are

for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home, are for

single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for diabetes or

for neonatal use.

Smart Diabetes Bluetooth Blood Glucose Monitoring System is intended for the quantitative measurement of the glucose

in fresh capillary whole blood drawn from fingertip, palm, and forearm by a single patient (lay user) as an aid in the

management of diabetes. It is intended for self testing by persons at home, for single patient use only, and should not be

shared. It is intended for use outside the body (in-vitro diagnostic use only) and not for the diagnosis of or screening for

diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state times

(when glucose is not changing rapidly).

The Smart Diabetes Blood Glucose Test Strips are to be used for monitoring glucose concentration

of fresh capillary whole blood with Smart Diabetes Bluetooth Blood Glucose Meter. The test strips and associated meters

are for use with fingertip, forearm, and palm testing. The test strips are intended for self testing by individuals at home,

are for single-patient use only, and should not be shared. The test strips are not for the diagnosis of or screening for

diabetes or for neonatal use.

Smart Diabetes Glucose Control Solutions are intended for use with the Smart Diabetes Bluetooth meter and Smart

Diabetes test strips as a quality control check to verify that the meter and test strips are working properly together.

Medisign MM1000 BT MULTI Blood Glucose Monitoring System is intended for the quantitative measurement of the

glucose in fresh capillary 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 a professional

healthcare setting. It is intended for use outside the body (in-vitro diagnostic use) and not for the diagnosis of or screening

for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state

times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this

system.

The Medisign MM1000 MULTI Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh

capillary whole blood with Medisign MM1000 BT MULTI Blood Glucose Meter. The test strips and associated meter are

for use with 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. The

strips are not for the diagnosis of or screening for diabetes or for neonatal use.

Medisign MM1100 BT MULTI Blood Glucose Monitoring System is intended for the quantitative measurement of the

glucose in fresh capillary 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 a professional

healthcare setting. It is intended for use outside the body (in-vitro diagnostic use) and not for the diagnosis of or screening

for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state

times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this

system.

The Medisign MM1100 MULTI Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh

capillary whole blood with Medisign MM1100 BT MULTI Blood Glucose Meter. The test strips and associated meter are

for use with 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. The

strips are not for the diagnosis of or screening for diabetes or for neonatal use.

Medisign MM1200 BT MULTI Blood Glucose Monitoring System is intended for the quantitative measurement of the

glucose in fresh capillary 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 a professional

healthcare setting. It is intended for use outside the body (in-vitro diagnostic use) and not for the diagnosis of or screening

for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state

times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this

system.

The Medisign MM1200 MULTI Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh

capillary whole blood with Medisign MM1200 BT MULTI Blood Glucose Meter. The test strips and associated meter are

for use with 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. The

strips are not for the diagnosis of or screening for diabetes or for neonatal use.

Smart Diabetes Bluetooth Pro Blood Glucose Monitoring System is intended for the quantitative measurement of the

glucose in fresh capillary 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 a professional

healthcare setting. It is intended for use outside the body (in-vitro diagnostic use) and not for the diagnosis of or screening

for diabetes or for neonatal use. The alternative site testing (palm and forearm) should be done only during steady state

times (when glucose is not changing rapidly). Only auto-disabling, single use lancing devices should be used with this

system.

The Smart Diabetes Pro Blood Glucose Test Strips are to be used for monitoring glucose concentration of fresh capillary

whole blood with Smart Diabetes Bluetooth Pro Blood Glucose Meter. The test strips and associated meter are for use

with 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. The

strips are not for the diagnosis of or screening for diabetes or for neonatal use.

Smart Diabetes Glucose Control Solutions are for use with both the Smart Diabetes Bluetooth Pro meter and Smart

Diabetes test strips as a quality control check to verify that the meter and test strips are working properly together.

Indications for use as stated in the FDA summary.

Also cleared against K111456

1 other device cites the same predicate.

  • K133260Medisign Blood Glucse Monitoring System, Medisign Multi Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd. · 2014

More from Tianjin Empecs Medical Device Co., Ltd.

4 FDA decisions under this applicant name. See the company

  • K162564Medisign GH81 Blood Glucose Monitoring System, Medisign GH82 Blood Glucose Monitoring System, Medisign GH83…Tianjin Empecs Medical Device Co., Ltd. · 2017
  • K133260Medisign Blood Glucse Monitoring System, Medisign Multi Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd. · 2014
  • K111456Medisign Blood Glucose Monitoring SystemTianjin Empecs Medical Device Co., Ltd. · 2012

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/K152534 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152534: Medisign MM1000 BT Blood Glucose Monitoring System, Medisign MM1100 BT Blood Glucose Monitoring System, Medisign MM1200 BT Blood Glucose Monitoring System, Smart Diabetes Bluetooth Blood Glucose Monitoring System, Medisign MM 1000 BT MULTI Blood Glucose Monitoring System, Medisign MM 1100 BT MULTI Blood Glucose Monitoring System, Medisign MM 1200 BT MULTI Blood Glucose Monitoring System, Smart Diabetes Bluetooth Pro 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/K152534

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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