510(k) · Cleared
ClearedOn Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Oct 10, 2025 after a 270-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 10, 2025
- Review
- 270 days
- Class
- Class II
- Product code
- NBW
- 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 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?
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 NBW devicesNBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 On Call® Sure GK Blood Glucose & Ketone Monitoring System is comprised of the On Call® Sure GK Blood Glucose & Ketone Meter, the On Call® Sure Blood Glucose Test Strips, and the On Call® Sure Blood Ketone Test Strips. The On Call® Sure GK Blood Glucose & Ketone Monitoring System is intended to quantitatively measure blood glucose or blood ketone in fresh capillary whole blood from the fingertip. The system is intended for self-testing by people with…
Read the full statement (261 words)
The On Call® Sure GK Blood Glucose & Ketone Monitoring System is comprised of the On Call® Sure GK Blood Glucose & Ketone Meter, the On Call® Sure Blood Glucose Test Strips, and the On Call® Sure Blood Ketone Test Strips.
The On Call® Sure GK Blood Glucose & Ketone Monitoring System is intended to quantitatively measure blood glucose or blood ketone in fresh capillary whole blood from the fingertip. The system is intended for self-testing by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control program. The system is for in vitro diagnostic use. It should only be used by a single patient and should not be shared. It is not intended for diagnosis or screening of diabetes or for neonatal use.
The On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System is comprised of the On Call® Sure Sync GK Blood Glucose & Ketone Meter, the On Call® Sure Blood Glucose Test Strips, and the On Call® Sure Blood Ketone Test Strips.
The On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System is intended to quantitatively measure blood glucose or blood ketone in fresh capillary whole blood from the fingertip. The system is intended for self-testing by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control program. The system is for in vitro diagnostic use. It should only be used by a single patient and should not be shared. It is not intended for diagnosis or screening of diabetes or for neonatal use.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K250085 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250085: On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone 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/K250085
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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