510(k) · Cleared
ClearedAcon on Call Vivid Pal Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Nov 21, 2012 after a 127-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Nov 21, 2012
- Review
- 127 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
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What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 On Callo Vivid Pal Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in fresh capillary whole blood from the, fingertip by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternate (forearm and palm) testing sites should be used only when blood glucose level is not changing rapidly. The On Call@ Vivid Blood Pal Glucose Monitoring System…
Read the full statement (201 words)
The On Callo Vivid Pal Blood Glucose Monitoring System is an electrochemical enzymatic assay for the quantitative detection of glucose in fresh capillary whole blood from the, fingertip by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. Alternate (forearm and palm) testing sites should be used only when blood glucose level is not changing rapidly. The On Call@ Vivid Blood Pal Glucose Monitoring System is intended to be used by a single patient and should not be shared. It is for in vitro diagnostic use only.
The On Call Vivid Blood Pal Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes mellitus, or use on neonates.
The On Call Vivid Pal Blood Glucose Test Strips are used with the On Call Vivid Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertip, forearm and palm.
The On Call Vivid Pal Blood Glucose Control Solution is for use with the On Call Vivid Pal Blood Glucose Meter and Strips as a quality control check to verify that the meter and test strips are working together properly and that the test is performing correctly.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K122110 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122110: Acon on Call Vivid Pal 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/K122110
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026