510(k) · Cleared
ClearedAssure Prism multi 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 Aug 7, 2015 as substantially equivalent to K131419 (I-Sens, Inc., 2013) after a 98-day review. Its family tree reaches back 5 generations to 2003.
- Decided
- Aug 7, 2015
- Review
- 98 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K024194 (2003). No later device cites it as a predicate yet.
- Root · 5 generations backK024194 One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 2003 · Recalled
- 4 generations backK080923 Caresens Blood Glucose Monitoring System; Caresens II Meter, Model…I-Sens, Inc. · 2008
- 3 generations backK083468 Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model…I-Sens, Inc. · 2009
- 2 generations backK103278 Acura Plus Blood Glucose Monitoring System; Acura Plus Blood Glucose…I-Sens, Inc. · 2011
- 1 generation backK131419 Acura Plus Multi Blood Glucose Monitoring SystemI-Sens, Inc. · 2013
- This deviceK151164 Assure Prism multi Blood Glucose Monitoring SystemI-Sens, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems | Lifescan, Inc. | 2003 | 5 |
| −4 | K080923 | Caresens Blood Glucose Monitoring System; Caresens II Meter, Model GM505C… | I-Sens, Inc. | 2008 | — |
| −3 | K083468 | Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or… | I-Sens, Inc. | 2009 | — |
| −2 | K103278 | Acura Plus Blood Glucose Monitoring System; Acura Plus Blood Glucose Meter… | I-Sens, Inc. | 2011 | — |
| −1 | K131419 | Acura Plus Multi Blood Glucose Monitoring System | I-Sens, Inc. | 2013 | — |
| 0 (this device) | K151164 | Assure Prism multi Blood Glucose Monitoring System | I-Sens, Inc. | 2015 | — |
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 |
|---|---|---|---|
| * | K131419 | Acura Plus Multi Blood Glucose Monitoring SystemSummary page 4…5, Chemistry Device class: Class II Predicate Device Device name: ACURA Plus Multi Blood Glucose Monitoring System Information 510(k) number: K131419 Device The Assure Prism multi Blood Glucose Monitoring System (BGMS) consists of a Description multi use blood… | 2013 |
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 12 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 5 ancestors has a recall of any class.
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. 2015, 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 Assure® Prism multi Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites (forearm, palm, thigh, and calf). Alternative site testing should be used only during steady-state blood glucose conditions. The system is intended for use outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional…
Read the full statement (143 words)
The Assure® Prism multi Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in
fresh capillary whole blood samples drawn from the fingertips and alternative sites (forearm, palm, thigh, and calf).
Alternative site testing should be used only during steady-state blood glucose conditions. The system is intended for use
outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an
aid to monitor the effectiveness of diabetes control. The system is only used with auto-disabling, single use lancing
device. It is not intended for use on neonates and is not for the diagnosis or screening of diabetes.
Assure® Prism multi Blood Glucose Test Strips are for use with the Assure® Prism multi blood glucose meter to
quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151164 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151164: Assure Prism multi 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/K151164
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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