510(k) · Cleared
ClearedCaresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B or GM5051C (Color)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I-Sens, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Feb 10, 2009 as substantially equivalent to K080923 (I-Sens, Inc., 2008) and 1 other predicate after a 78-day review. Its family tree reaches back 2 generations to 2003. 21 later devices descend from it.
- Decided
- Feb 10, 2009
- Review
- 78 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K024194 (2003). 21 later devices descend from it, 12 citing it directly.
- Root · 2 generations backK024194 One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 2003 · Recalled
- 1 generation backK080923 Caresens Blood Glucose Monitoring System; Caresens II Meter, Model…I-Sens, Inc. · 2008
- This deviceK083468 Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model…I-Sens, Inc. · 2009
- Descendant · cites it directly · 5 of its ownK160742 NoCoding1 Plus Blood Glucose Monitoring SystemI-Sens, Inc. · 2016
- Descendant · 2 generations on · 3 of its ownK170614 CareSens N Premier Blood Glucose Monitoring System, CareSens N…I-Sens, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK103278 Acura Plus Blood Glucose Monitoring System; Acura Plus Blood Glucose…I-Sens, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK131419 Acura Plus Multi Blood Glucose Monitoring SystemI-Sens, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK121133 Caresens N Voice Blood Glucose Monitoring SystemI-Sens, Inc. · 2012
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K160742NoCoding1 Plus Blood Glucose Monitoring SystemI-Sens, Inc. · 2016 · cites it directly5descendants
- K170614CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose…I-Sens, Inc. · 2017 · 2 generations on3descendants
- K103278Acura Plus Blood Glucose Monitoring System; Acura Plus Blood Glucose Meter; Acura…I-Sens, Inc. · 2011 · cites it directly2descendants
- K131419Acura Plus Multi Blood Glucose Monitoring SystemI-Sens, Inc. · 2013 · 2 generations on1descendant
- K121133Caresens N Voice Blood Glucose Monitoring SystemI-Sens, Inc. · 2012 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems | Lifescan, Inc. | 2003 | 5 |
| −1 | K080923 | Caresens Blood Glucose Monitoring System; Caresens II Meter, Model GM505C… | I-Sens, Inc. | 2008 | — |
| 0 (this device) | K083468 | Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or… | I-Sens, Inc. | 2009 | — |
| +1 | K160742 | NoCoding1 Plus Blood Glucose Monitoring System | I-Sens, Inc. | 2016 | — |
| +2 | K170614 | CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT… | I-Sens, Inc. | 2017 | — |
| +1 | K103278 | Acura Plus Blood Glucose Monitoring System; Acura Plus Blood Glucose Meter… | I-Sens, Inc. | 2011 | — |
| +2 | K131419 | Acura Plus Multi Blood Glucose Monitoring System | I-Sens, Inc. | 2013 | — |
| +1 | K121133 | Caresens N Voice Blood Glucose Monitoring System | I-Sens, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K080923 | Caresens Blood Glucose Monitoring System; Caresens II Meter, Model GM505C; Caresens Pop…Summary page 1…Special Submitter's Previously Cleared Device: Name - CareSens Blood Glucose Monitoring System 5 10(k) number - k080923 Introduction: This 5 10(k) submission contains information/data, on modifications made… | 2008 |
| * | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsSummary page 2…systems by i-SENS, Inc. (k080923) and the OneTouch® Ultra® Blood Glucose Monitoring System by LifeScan, Inc. (k024194). I Device Description: Care… | 2003 |
What descends from it? (21)
See all 2112 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160742 | NoCoding1 Plus Blood Glucose Monitoring System | 2016 | 5 |
| K103278 | Acura Plus Blood Glucose Monitoring System; Acura Plus Blood Glucose Meter; Acura… | 2011 | 2 |
| K121133 | Caresens N Voice Blood Glucose Monitoring System | 2012 | 1 |
| K103396 | Cool Blood Glucose Monitoring System, Blood Glucose Meter, Cool Control Solution | 2011 | 1 |
| K151658 | Gmate Origin Blood Glucose Monitoring System | 2015 | 0 |
| K141656 | Gmate Mini Blood Glucose Monitoring System, Gmate Step Blood Glucose Monitoring System | 2015 | 0 |
| K130696 | Caresens N Link Blood Glucose Monitoring System; Caresens N Link Multi Blood Blucose… | 2013 | 0 |
| K123007 | Veri-Q MGD-1001 Blood Glucose Monitoring System, Veri-Q Plus MGD-1001 Blood Glucose… | 2013 | 0 |
| K123016 | Veri-Q Self-Testing and Veri-Q Plus MGD-2001 Blood Glucose Monitoring Systems | 2013 | 0 |
| K120759 | Caresens N Mini Blood Glucose Monitoring System, Mini Blood Glucose Meter, Blood Glucose… | 2012 | 0 |
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 6 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K160742 (I-Sens, Inc., 2016) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K080923.
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. 2009, 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 CareSens N Meter is 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 N Blood Glucose System should be used only for testing outside the body (in vitro diagnostic use only). Do not use the system for the diagnosis or screening of diabetes. Testing sites include the traditional fingertip testing along with alternate…
Read the full statement (188 words)
The CareSens N Meter is 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 N Blood Glucose System should be used only for testing
outside the body (in vitro diagnostic use only). Do not use the system for the diagnosis or
screening of diabetes. Testing sites include the traditional fingertip testing along with alternate
sites testing on forearm, palm, thigh and calf.
CareSens N Test Strip is used with the CareSens N Blood Glucose Meter for quantitatively
measuring glucose in capillary whole blood. The CareSens N Test Strip is intended for self-
testing outside the body (in vitro diagnostic use only). Do not use the system for the diagnosis of
diabetes without the guidance of healthcare professional. Testing sites include the traditional
fingertip testing along with alternate sites testing on forearm, palm, thigh and calf.
CareSens Control A&B Solutions are a red liquid to check that both the meters and test strips are
working together properly. It contains a known range of glucose as written on the bottle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083468 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083468: Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B or GM5051C (Color).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083468
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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