510(k) · Cleared
ClearedAcura Plus Blood Glucose Monitoring System; Acura Plus Blood Glucose Meter; Acura Control Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I-Sens, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Oct 28, 2011 as substantially equivalent to K083468 (I-Sens, Inc., 2009) after a 357-day review. Its family tree reaches back 3 generations to 2003. 2 later devices descend from it.
- Decided
- Oct 28, 2011
- Review
- 357 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K024194 (2003). 2 later devices descend from it, 1 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 deviceK103278 Acura Plus Blood Glucose Monitoring System; Acura Plus Blood Glucose…I-Sens, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK131419 Acura Plus Multi Blood Glucose Monitoring SystemI-Sens, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK151164 Assure Prism multi Blood Glucose Monitoring SystemI-Sens, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See allView 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) | 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 | — |
| +2 | K151164 | Assure Prism multi Blood Glucose Monitoring System | I-Sens, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 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 CGA? 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 CGA device
- #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 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 3…ea Tel. 82-2-916-6191 Predicate Device: 1) Device name: CareSens N Blood Glucose Monitoring System 5 10(k) Number: k083468 2) Device name: ACURA Blood Glucose Monitoring System 5 10O(k) Number… | 2009 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131419 | Acura Plus Multi Blood Glucose Monitoring System | 2013 | 1 |
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 8 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K131419 (I-Sens, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 11 other devices also cite its predicate K083468.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ACURA PLUS Blood Glucose Monitoring System consists of a measuring meter, test strips and control solutions. The ACURA PLUS Blood Glucose Meter is intended for use with the ACURA PLUS Blood Glucose Test Strips for the quantitative measurement of glucose in capillary whole blood from the fingertip and the alternate sites such as forearm, palm, thigh and calf. The alternate site testing should be used only during steady-state blood glucose conditions.…
Read the full statement (177 words)
The ACURA PLUS Blood Glucose Monitoring System consists of a measuring meter, test strips and control solutions. The ACURA PLUS Blood Glucose Meter is intended for use with the ACURA PLUS Blood Glucose Test Strips for the quantitative measurement of glucose in capillary whole blood from the fingertip and the alternate sites such as forearm, palm, thigh and calf. The alternate site testing should be used only during steady-state blood glucose conditions. The ACURA PLUS Control Solutions are for use with the ACURA PLUS Meter and ACURA PLUS Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The ACURA PLUS Blood Glucose Monitoring System is intended for self testing outside the body by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. 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 of or screening for diabetes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103278 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103278: Acura Plus Blood Glucose Monitoring System; Acura Plus Blood Glucose Meter; Acura Control Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103278
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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