510(k) · Cleared
ClearedCareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose Monitoring System
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 Oct 19, 2017 as substantially equivalent to K160742 (I-Sens, Inc., 2016) after a 232-day review. Its family tree reaches back 4 generations to 2003. 3 later devices descend from it.
- Decided
- Oct 19, 2017
- Review
- 232 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K024194 (2003). 3 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK024194 One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 2003 · Recalled
- 3 generations backK080923 Caresens Blood Glucose Monitoring System; Caresens II Meter, Model…I-Sens, Inc. · 2008
- 2 generations backK083468 Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model…I-Sens, Inc. · 2009
- 1 generation backK160742 NoCoding1 Plus Blood Glucose Monitoring SystemI-Sens, Inc. · 2016
- This deviceK170614 CareSens N Premier Blood Glucose Monitoring System, CareSens N…I-Sens, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK230625 ReliOn Premier BLU Blood Glucose Monitoring SystemI-Sens, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK181273 GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD…I-Sens, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK180866 CareSens S Fit Blood Glucose Monitoring SystemI-Sens, Inc. · 2018
Most influential descendants
Showing 3 of 3 · See all- K230625ReliOn Premier BLU Blood Glucose Monitoring SystemI-Sens, Inc. · 2023 · cites it directly0descendants
- K181273GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood…I-Sens, Inc. · 2018 · cites it directly0descendants
- K180866CareSens S Fit Blood Glucose Monitoring SystemI-Sens, Inc. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems | Lifescan, Inc. | 2003 | 5 |
| −3 | K080923 | Caresens Blood Glucose Monitoring System; Caresens II Meter, Model GM505C… | I-Sens, Inc. | 2008 | — |
| −2 | 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 | — |
| 0 (this device) | K170614 | CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT… | I-Sens, Inc. | 2017 | — |
| +1 | K230625 | ReliOn Premier BLU Blood Glucose Monitoring System | I-Sens, Inc. | 2023 | — |
| +1 | K181273 | GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine… | I-Sens, Inc. | 2018 | — |
| +1 | K180866 | CareSens S Fit Blood Glucose Monitoring System | I-Sens, Inc. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K160742 | NoCoding1 Plus Blood Glucose Monitoring SystemSummary page 5…Clinical Chemistry 75 Blood Glucose Test System Predicate Device NoCoding1 Plus Blood Glucose Monitoring System, K160742. Device Description CareSens N Premier brand of Blood Glucose Monitoring System is designed… | 2016 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K230625 (I-Sens, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K160742.
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. 2017, 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 Premier Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens N Premier Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and…
Read the full statement (259 words)
The CareSens N Premier Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens N Premier Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
The CareSens N Single Blood Glucose Test Strips are for use with the CareSens N Premier Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.
The CareSens N Premier BT Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The CareSens N Premier BT Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
The CareSens N Single Blood Glucose Test Strips are for use with the CareSens N Premier BT Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170614 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170614: CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT 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/K170614
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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