510(k) · Cleared
ClearedNoCoding1 Plus 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 Dec 16, 2016 as substantially equivalent to K083468 (I-Sens, Inc., 2009) after a 274-day review. Its family tree reaches back 3 generations to 2003. 5 later devices descend from it.
- Decided
- Dec 16, 2016
- Review
- 274 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K024194 (2003). 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK024194 One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 2003 · Recalled
- 2 generations backK080923 Caresens Blood Glucose Monitoring System; Caresens II Meter, Model…I-Sens, Inc. · 2008
- 1 generation backK083468 Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model…I-Sens, Inc. · 2009
- This deviceK160742 NoCoding1 Plus Blood Glucose Monitoring SystemI-Sens, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK170614 CareSens N Premier Blood Glucose Monitoring System, CareSens N…I-Sens, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK230625 ReliOn Premier BLU Blood Glucose Monitoring SystemI-Sens, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK181273 GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD…I-Sens, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK180866 CareSens S Fit Blood Glucose Monitoring SystemI-Sens, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK171480 NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood…I-Sens, Inc. · 2017
Most influential descendants
Showing 5 of 5 · See all- K170614CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT Blood Glucose…I-Sens, Inc. · 2017 · cites it directly3descendants
- K230625ReliOn Premier BLU Blood Glucose Monitoring SystemI-Sens, Inc. · 2023 · 2 generations on0descendants
- K181273GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood…I-Sens, Inc. · 2018 · 2 generations on0descendants
- K180866CareSens S Fit Blood Glucose Monitoring SystemI-Sens, Inc. · 2018 · 2 generations on0descendants
- K171480NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring SystemI-Sens, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems | Lifescan, Inc. | 2003 | 5 |
| −2 | K080923 | Caresens Blood Glucose Monitoring System; Caresens II Meter, Model GM505C… | I-Sens, Inc. | 2008 | — |
| −1 | K083468 | Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or… | I-Sens, Inc. | 2009 | — |
| 0 (this device) | K160742 | NoCoding1 Plus Blood Glucose Monitoring System | I-Sens, Inc. | 2016 | — |
| +1 | K170614 | CareSens N Premier Blood Glucose Monitoring System, CareSens N Premier BT… | I-Sens, Inc. | 2017 | — |
| +2 | K230625 | ReliOn Premier BLU Blood Glucose Monitoring System | I-Sens, Inc. | 2023 | — |
| +2 | K181273 | GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine… | I-Sens, Inc. | 2018 | — |
| +2 | K180866 | CareSens S Fit Blood Glucose Monitoring System | I-Sens, Inc. | 2018 | — |
| +1 | K171480 | NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose… | I-Sens, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K083468 | Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B…Summary page 5…gil, Seocho-gu 06646 Seoul, Korea Tel: +82-2-916-6191 Fax: +82-2-942-2514 Predicate Device CareSens N Blood Glucose Monitoring System (k083468) Device Description The NoCoding1 Plus Blood Glucose Monitoring System (BGMS) consists of a blood g… | 2009 |
What descends from it? (5)
2 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 13 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K170614 (I-Sens, Inc., 2017) has gone furthest, with 3 descendants of its own.
- 11 other devices also cite its predicate K083468.
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. 2016, 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 NoCoding1 Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. The NoCoding1 Plus Blood Glucose Monitoring System is intended for self-testing outside the body (for 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…
Read the full statement (165 words)
The NoCoding1 Plus Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip. The NoCoding1 Plus Blood Glucose Monitoring System is intended for self-testing outside the body (for 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 NoCoding1 Blood Glucose Test Strips are for use with the NoCoding1 Plus Blood Glucose Meters to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip.
The NoCoding1 Glucose Control Solutions are for use with the NoCoding1 Plus Blood Glucose Meters and NoCoding1 Blood Glucose Test Strips to check that the meter and the test strips are working together properly and that the test is performing correctly.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160742 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160742: NoCoding1 Plus 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/K160742
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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