510(k) Report

510(k) · Cleared

Cleared

Caresens Blood Glucose Monitoring System; Caresens II Meter, Model GM505C; Caresens Pop Meter, Model GM505EA or GM505EB

K080923510(k) TraditionalCleared Oct 17, 2008198-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

I-Sens, Inc. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Oct 17, 2008 as substantially equivalent to K024194 (Lifescan, Inc., 2003) after a 198-day review. Its family tree reaches back 1 generation to 2003. 22 later devices descend from it.

Decided
Oct 17, 2008
Review
198 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K024194 (2003). 22 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2009: 1 descendant cleared2012: 4 descendants cleared2016: 1 descendant cleared2011: 2 descendants cleared2015: 3 descendants cleared2013: 5 descendants cleared2017: 2 descendants cleared2018: 2 descendants cleared2023: 1 descendant clearedK024194 · One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems · Lifescan, Inc. · 2003 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 11 descendants3 generations forward: 5 descendants4 generations forward: 4 descendants K024194 · One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems · Lifescan, Inc. · 2003 · recalled0
  1. Root · 1 generation backK024194 One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 2003 · Recalled
  2. This deviceK080923 Caresens Blood Glucose Monitoring System; Caresens II Meter, Model…I-Sens, Inc. · 2008
  3. Descendant · cites it directly · 21 of its ownK083468 Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model…I-Sens, Inc. · 2009
  4. Descendant · 2 generations on · 5 of its ownK160742 NoCoding1 Plus Blood Glucose Monitoring SystemI-Sens, Inc. · 2016
  5. Descendant · 3 generations on · 3 of its ownK170614 CareSens N Premier Blood Glucose Monitoring System, CareSens N…I-Sens, Inc. · 2017
  6. Descendant · 2 generations on · 2 of its ownK103278 Acura Plus Blood Glucose Monitoring System; Acura Plus Blood Glucose…I-Sens, Inc. · 2011
  7. Descendant · 3 generations on · 1 of its ownK131419 Acura Plus Multi Blood Glucose Monitoring SystemI-Sens, Inc. · 2013

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12011: 22012: 42013: 52015: 32016: 12017: 22018: 22023: 1
2009high 5 (2013) · low 0 (2014)2026

Most influential descendants

Showing 5 of 22 · See all
  • K083468Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B…I-Sens, Inc. · 2009 · cites it directly21descendants
  • K160742NoCoding1 Plus Blood Glucose Monitoring SystemI-Sens, Inc. · 2016 · 2 generations on5descendants
  • K170614CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose…I-Sens, Inc. · 2017 · 3 generations on3descendants
  • K103278Acura Plus Blood Glucose Monitoring System; Acura Plus Blood Glucose Meter; Acura…I-Sens, Inc. · 2011 · 2 generations on2descendants
  • K131419Acura Plus Multi Blood Glucose Monitoring SystemI-Sens, Inc. · 2013 · 3 generations on1descendant
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)K080923Caresens Blood Glucose Monitoring System; Caresens II Meter, Model GM505C…I-Sens, Inc.2008—
+1K083468Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or…I-Sens, Inc.2009—
+2K160742NoCoding1 Plus Blood Glucose Monitoring SystemI-Sens, Inc.2016—
+3K170614CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT…I-Sens, Inc.2017—
+2K103278Acura Plus Blood Glucose Monitoring System; Acura Plus Blood Glucose Meter…I-Sens, Inc.2011—
+3K131419Acura Plus Multi Blood Glucose Monitoring SystemI-Sens, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201120
201240
201350
201530
201610
201720
201820
202310
FIG. 1 — Lineage of K080923, 2003–2023Source: 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
*K024194One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems
Summary page 3
…otably, it is substantially equivalent to the currently marketed item, the OneTouch® Ultra® by LifeScan, Inc. Predicate Device 510(k) number: K024194 Similarities Item Device…
Lifescan, Inc.20035

Also cleared against K024194: 14 other devices →

What descends from it? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K083468Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B…I-Sens, Inc.200921
K093475Basesens Blood Glucose Monitoring SystemHygeia, Inc.20100

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, K083468 (I-Sens, Inc., 2009) has gone furthest, with 21 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?

The CareSens II, CareSens POP Meters are used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management at home or in clinical settings. CareSens Blood Glucose System is only for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip along with alternate sites (forearm, palm, thigh and calf) CareSens Test Strips work with…

Read the full statement (176 words)

The CareSens II, CareSens POP Meters are used for the quantitative measurement of glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management at home or in clinical settings. CareSens Blood Glucose System is only for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip along with alternate sites (forearm, palm, thigh and calf)

CareSens Test Strips work with the CareSens 11, CareSens POP meters to quantitatively measure glucose level in capillary whole blood as an aid in monitoring the effectiveness of diabetes management in at home or in clinical settings. CareSens Blood Glucose System is only for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip along with alternate sites (forearm, palm, thigh and calf)

CareSens Normal and Middle Control Solutions are a red liquid which is to be used to check that both the CareSens meters and CareSens test strips are working together properly. It contains a known range of glucose as specified on the vial.

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
  • K073030AG-605 Blood Glucose Monitoring SystemAndon Health Co, Ltd. · 2008
  • K061431Easygluco, Model Igm-0002 G2U. S. Diagnostics, Inc. · 2007
  • K052469GlucopackHealthpia America Corp. · 2006

More from I-Sens, Inc.

28 FDA decisions under this applicant name. See the company

  • K260689CVS Advanced PLUS Blood Glucose Monitoring SystemI-Sens, Inc. · 2026
  • K230625ReliOn Premier BLU Blood Glucose Monitoring SystemI-Sens, Inc. · 2023
  • K222656LDE4 Lancing DeviceI-Sens, Inc. · 2022
  • K201394CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring SystemI-Sens, Inc. · 2021
  • K201551KetoSens BT Blood B-Ketone Monitoring SystemI-Sens, Inc. · 2020

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/K080923 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080923: Caresens Blood Glucose Monitoring System; Caresens II Meter, Model GM505C; Caresens Pop Meter, Model GM505EA or GM505EB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080923

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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