510(k) Report

510(k) · Cleared

Cleared

AG-605 Blood Glucose Monitoring System

K073030510(k) TraditionalCleared Jul 21, 2008269-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

Andon Health Co, Ltd. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Jul 21, 2008 as substantially equivalent to K024194 (Lifescan, Inc., 2003) after a 269-day review. Its family tree reaches back 1 generation to 2003. 15 later devices descend from it.

Decided
Jul 21, 2008
Review
269 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K024194 (2003). 15 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2011: 2 descendants cleared2010: 1 descendant cleared2012: 3 descendants cleared2013: 1 descendant cleared2014: 2 descendants cleared2017: 2 descendants cleared2016: 2 descendants cleared2015: 1 descendant cleared2019: 1 descendant clearedK024194 · One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems · Lifescan, Inc. · 2003 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 2 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants5 generations forward: 3 descendants6 generations forward: 1 descendant K024194 · One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems · Lifescan, Inc. · 2003 · recalled0+5
  1. Root · 1 generation backK024194 One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 2003 · Recalled
  2. This deviceK073030 AG-605 Blood Glucose Monitoring SystemAndon Health Co, Ltd. · 2008
  3. Descendant · cites it directly · 11 of its ownK093262 AG-608 Blood Glucose Monitoring System and AG-610 Blood Glucose…Andon Medical Co., Ltd. · 2010
  4. Descendant · 2 generations on · 10 of its ownK110017 AG-608N Blood Glucose Monitoring SystemAndon Medical Co., Ltd. · 2012
  5. Descendant · 3 generations on · 7 of its ownK120813 Blood Glucose Monitoring SystemAndon Medical Co., Ltd. · 2012
  6. Descendant · 3 generations on · 3 of its ownK123935 Ihealth BG5/BG5L Wireless Smart Glucose Monitoring SystemAndon Medical Co., Ltd. · 2013
  7. Descendant · 4 generations on · 2 of its ownK153278 Wireless Smart Gluco-Monitoring SystemAndon Health Co, Ltd. · 2016

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2010: 12011: 22012: 32013: 12014: 22015: 12016: 22017: 22019: 1
2010high 3 (2012) · low 0 (2018)2026

Most influential descendants

Showing 5 of 15 · See all
  • K093262AG-608 Blood Glucose Monitoring System and AG-610 Blood Glucose Monitoring SystemAndon Medical Co., Ltd. · 2010 · cites it directly11descendants
  • K110017AG-608N Blood Glucose Monitoring SystemAndon Medical Co., Ltd. · 2012 · 2 generations on10descendants
  • K120813Blood Glucose Monitoring SystemAndon Medical Co., Ltd. · 2012 · 3 generations on7descendants
  • K123935Ihealth BG5/BG5L Wireless Smart Glucose Monitoring SystemAndon Medical Co., Ltd. · 2013 · 3 generations on3descendants
  • K153278Wireless Smart Gluco-Monitoring SystemAndon Health Co, Ltd. · 2016 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K024194One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc.20035
0 (this device)K073030AG-605 Blood Glucose Monitoring SystemAndon Health Co, Ltd.2008—
+1K093262AG-608 Blood Glucose Monitoring System and AG-610 Blood Glucose Monitoring…Andon Medical Co., Ltd.2010—
+2K110017AG-608N Blood Glucose Monitoring SystemAndon Medical Co., Ltd.2012—
+3K120813Blood Glucose Monitoring SystemAndon Medical Co., Ltd.2012—
+3K123935Ihealth BG5/BG5L Wireless Smart Glucose Monitoring SystemAndon Medical Co., Ltd.2013—
+4K153278Wireless Smart Gluco-Monitoring SystemAndon Health Co, Ltd.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201120
201230
201310
201420
201510
201620
201720
201910
FIG. 1 — Lineage of K073030, 2003–2019Source: 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
*K024194One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems
Summary page 1
…FR 862.1345, Glucose Monitor) Product code: CGA Predicate Device: One Touch Ultra Blood Glucose Monitoring system of Life Scan 510k number: K024194 Device description: AG-605 & AG-606 Blood Glucose Monitoring System consists of a blood glucose meter, test strips, two levels…
Lifescan, Inc.20035

Also cleared against K024194: 14 other devices →

What descends from it? (15)

See all 15

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K093262AG-608 Blood Glucose Monitoring System and AG-610 Blood Glucose Monitoring SystemAndon Medical Co., Ltd.201011
K101307Blood Glucose Monitoring System, Models AG-6081 and AG-6951Andon Medical Co., Ltd.20111
K093755AG-695 Single and Multi Blood Glucose Monitoring System/AG-696 Single and Multi Blood…Andon Medical Co., Ltd.20110

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?

  • Its one ancestor has a recall.
  • Of its descendants, K093262 (Andon Medical Co., Ltd., 2010) has gone furthest, with 11 descendants of its own.
  • 14 other devices also cite its predicate K024194.

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. 2008, 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?

AG-605 & AG-606 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for both lay uses by people with diabetes and in a clinical setting by health care professionals, as an aid to monitoring levels in Diabetes Mellitus. Not for use on neonates.

Indications for use as stated in the FDA summary.

Also cleared against K024194

14 other devices cite the same predicate.

  • K082683SD Check GoldStandard Diagnostics, Inc. · 2009
  • K082201G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024AU. S. Diagnostics, Inc. · 2009
  • K083468Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B or GM5051C (Color)I-Sens, Inc. · 2009
  • K080923Caresens Blood Glucose Monitoring System; Caresens II Meter, Model GM505C; Caresens Pop Meter, Model GM505EA…I-Sens, Inc. · 2008
  • K061431Easygluco, Model Igm-0002 G2U. S. Diagnostics, Inc. · 2007
  • K052469GlucopackHealthpia America Corp. · 2006

More from Andon Health Co, Ltd.

92 FDA decisions under this applicant name. See the company

  • K251113iHealth Compare Wireless Blood Pressure Monitor (BP-300C);iHealth Compare Pro Wireless Blood Pressure…Andon Health Co, Ltd. · 2025
  • K241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripAndon Health Co, Ltd. · 2024
  • K234041Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic Electronic Blood Pressure…Andon Health Co, Ltd. · 2024
  • K222869Arm Blood Pressure MonitorAndon Health Co, Ltd. · 2023
  • K222867AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS)Andon Health Co, Ltd. · 2022

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/K073030 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073030: AG-605 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/K073030

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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