510(k) · Cleared
ClearedDario Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Labstyle Innovations, Ltd. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jul 19, 2017 as substantially equivalent to K150817 (Labstyle Innovations, Ltd., 2015) after a 251-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Jul 19, 2017
- Review
- 251 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K952279 (1995). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK952279 Precision Link Blood Glucose Data Management SystemMedisense, Inc. · 1995
- 6 generations backK994433 Connect Data Management SystemAbbott Diabetes Care, Inc. · 2000 · Recalled
- 5 generations backK062434 Zero-Click Data Management System, Model 8000-01528Agamatrix · 2006
- 4 generations backK101597 Wavesense Diabetes Manager Model Version 1.3.4Agamatrix · 2010
- 3 generations backK103544 Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager…Agamatrix, Inc. · 2011
- 2 generations backK131230 Gmate Smart Blood Glucose Monitoring System, Gmate Smart ApplicationPhilosys, Inc. · 2014
- 1 generation backK150817 Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd. · 2015 · Recalled
- This deviceK163159 Dario Blood Glucose Monitoring SystemLabstyle Innovations, Ltd. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K952279 | Precision Link Blood Glucose Data Management System | Medisense, Inc. | 1995 | — |
| −6 | K994433 | Connect Data Management System | Abbott Diabetes Care, Inc. | 2000 | 1 |
| −5 | K062434 | Zero-Click Data Management System, Model 8000-01528 | Agamatrix | 2006 | — |
| −4 | K101597 | Wavesense Diabetes Manager Model Version 1.3.4 | Agamatrix | 2010 | — |
| −3 | K103544 | Ibgstar Blood Glucose Monitoring System, Ibgstar Diabetes Manager Application… | Agamatrix, Inc. | 2011 | — |
| −2 | K131230 | Gmate Smart Blood Glucose Monitoring System, Gmate Smart Application | Philosys, Inc. | 2014 | — |
| −1 | K150817 | Dario Blood Glucose Monitoring System | Labstyle Innovations, Ltd. | 2015 | 1 |
| 0 (this device) | K163159 | Dario Blood Glucose Monitoring System | Labstyle Innovations, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 |
|---|---|---|---|
| * | K150817 | Dario Blood Glucose Monitoring SystemSummary page 4…t Code: NBW Classification System, Test, Blood Glucose, Over The Counter Name: Predicate Device: Dario Blood Glucose Monitoring System K150817 Device The Dario Blood Glucose Monitoring System is a compact, Description: all-in-one blood glucose meter t… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 6 companies; a new generation was cleared every 2.7 years on median.
- 2 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K150817.
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 Dario Blood Glucose Monitoring System consists of the Dario Blood Glucose Meter, Dario Glucose Test Strips, Dario Glucose Control Solutions and the Dario App as the display component of the Dario Blood Glucose Monitoring System. The Dario Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The Dario Blood Glucose Monitoring System is intended…
Read the full statement (163 words)
The Dario Blood Glucose Monitoring System consists of the Dario Blood Glucose Meter, Dario Glucose Test Strips, Dario Glucose Control Solutions and the Dario App as the display component of the Dario Blood Glucose Monitoring System. The Dario Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The Dario Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The Dario Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home to monitor the effectiveness of diabetes control. The Dario Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163159 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163159: Dario 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/K163159
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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