510(k) Report

510(k) · Cleared

Cleared

AP-1010 and AP-1020 Blood Glucose Monitoring System, Major Glucose Control Solution

K103044510(k) TraditionalCleared Feb 10, 2012484-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

Bestgen Biotech Corp. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Feb 10, 2012 as substantially equivalent to K090389 (Bestgen Biotech Corp., 2009) after a 484-day review. Its family tree reaches back 4 generations to 1997.

Decided
Feb 10, 2012
Review
484 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K964630 (1997). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestorK964630 · Glucometer Elite Blood Glucose Meter · Bayer Corp. · 1997K043311 · Ascensia Elite Diabetes Care System · Bayer Healthcare, LLC · 2004K062538 · Easy Check Blood Glucose Monitoring System · Diacare Corp. · 2007K090389 · AP-1000 Blood Glucose Monitoring System · Bestgen Biotech Corp. · 20091995200020052010
Other ancestors, by generation 4 generations back: 1 other ancestor K090389 · AP-1000 Blood Glucose Monitoring System · Bestgen Biotech Corp. · 2009K062538 · Easy Check Blood Glucose Monitoring System · Diacare Corp. · 2007K043311 · Ascensia Elite Diabetes Care System · Bayer Healthcare, LLC · 2004K964630 · Glucometer Elite Blood Glucose Meter · Bayer Corp. · 19970
  1. Root · 4 generations backK964630 Glucometer Elite Blood Glucose MeterBayer Corp. · 1997
  2. 3 generations backK043311 Ascensia Elite Diabetes Care SystemBayer Healthcare, LLC · 2004
  3. 2 generations backK062538 Easy Check Blood Glucose Monitoring SystemDiacare Corp. · 2007
  4. 1 generation backK090389 AP-1000 Blood Glucose Monitoring SystemBestgen Biotech Corp. · 2009
  5. This deviceK103044 AP-1010 and AP-1020 Blood Glucose Monitoring System, Major Glucose…Bestgen Biotech Corp. · 2012
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K964630Glucometer Elite Blood Glucose MeterBayer Corp.1997—
−3K043311Ascensia Elite Diabetes Care SystemBayer Healthcare, LLC2004—
−2K062538Easy Check Blood Glucose Monitoring SystemDiacare Corp.2007—
−1K090389AP-1000 Blood Glucose Monitoring SystemBestgen Biotech Corp.2009—
0 (this device)K103044AP-1010 and AP-1020 Blood Glucose Monitoring System, Major Glucose Control…Bestgen Biotech Corp.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K103044, 1997–2012Source: 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
*K090389AP-1000 Blood Glucose Monitoring System
Summary page 3
…ood Glucose Monitoring System. 5. Substantial Equivalence Information A. Predicate device name: AP-1000 Blood Glucose Monitoring System B. Predicate Knumber: k090389 C. Comparison with predicate: The modified AP-l0lO, AP-l0l0multi, AP-1020, and AP-lO2Omulti Blood Glucose Monitoring Syste…
Bestgen Biotech Corp.2009—

Also cleared against K090389: 3 other devices →

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 15 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
  • None of the 5 ancestors has a recall.
  • 3 other devices also cite its predicate K090389.

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. 2012, 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 AP-1010 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1010 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AP-1010 Blood Glucose Monitoring System is intended for self testing outside the body (invitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of…

Read the full statement (672 words)

The AP-1010 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1010 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AP-1010 Blood Glucose Monitoring System is intended for self testing outside the body (invitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-1010 Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP-1010 Blood Glucose Test Strips must be used with the AP-1010 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-1010multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1010multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multi-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-1010multi Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP-1010multi Blood Glucose Test Strips must be used with the AP-1010multi Blood Glucose Meter. Testing is done outside the body (InVitro diagnostic use). This system should only be used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-1020 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1020 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AP-1020 Blood Glucose Monitoring Systems is intended for self testing outside the body (invitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-1020 Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP-1020 Blood Glucose Test Strips must be used with the AP-1020 Blood Glucose Meter. Testing is done outside the body (in Vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-1020multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1020multi Blood Glucose Monitoring System is intended for testing outside the body (invitro diagnostic use) and is intended for multi-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-1020multi Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP-1020multi Blood Glucose Test Strips must be used with the AP-1020multi Blood Glucose Meter. Testing is done outside the body (InVitro diagnostic use). This system is only used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Indications for use as stated in the FDA summary.

Also cleared against K090389

3 other devices cite the same predicate.

  • K103230AP-3000 Blood Glucose Monitoring System, Major Glucose Control SolutionBestgen Biotech Corp. · 2012
  • K103116AP-2000, AP-2010, and AP-2020 Blood Glucose Monitoring SystemBestgen Biotech Corp. · 2012
  • K100437AP-1000 Blood Glucose Monitoring System, Model AP-1000, Major Glucose Control SolutionBestgen Biotech Corp. · 2012

More from Bestgen Biotech Corp.

6 FDA decisions under this applicant name. See the company

  • K103230AP-3000 Blood Glucose Monitoring System, Major Glucose Control SolutionBestgen Biotech Corp. · 2012
  • K103116AP-2000, AP-2010, and AP-2020 Blood Glucose Monitoring SystemBestgen Biotech Corp. · 2012
  • K100437AP-1000 Blood Glucose Monitoring System, Model AP-1000, Major Glucose Control SolutionBestgen Biotech Corp. · 2012
  • K090389AP-1000 Blood Glucose Monitoring SystemBestgen Biotech Corp. · 2009
  • K072274Major Iii Blood Glucose Monitoring SystemBestgen Biotech Corp. · 2008

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/K103044 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103044: AP-1010 and AP-1020 Blood Glucose Monitoring System, Major Glucose Control Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103044

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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