510(k) · Cleared
ClearedOn Call Express Pro Blood Glucose 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 Sep 5, 2015 as substantially equivalent to K132086 (ACON Laboratories, Inc., 2013) after an 85-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Sep 5, 2015
- Review
- 85 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002134 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK002134 One Touch Ultra Blood Glucose Monitoring SystemSelfcare, Inc. · 2000
- 2 generations backK112653 ON Call Vivid Blood Glucose Monitoring SystemsACON Laboratories, Inc. · 2012
- 1 generation backK132086 ON Call Express Blood Glucose Monitoring SystemACON Laboratories, Inc. · 2013
- This deviceK151595 On Call Express Pro Blood Glucose Monitoring SystemACON Laboratories, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002134 | One Touch Ultra Blood Glucose Monitoring System | Selfcare, Inc. | 2000 | — |
| −2 | K112653 | ON Call Vivid Blood Glucose Monitoring Systems | ACON Laboratories, Inc. | 2012 | — |
| −1 | K132086 | ON Call Express Blood Glucose Monitoring System | ACON Laboratories, Inc. | 2013 | — |
| 0 (this device) | K151595 | On Call Express Pro Blood Glucose Monitoring System | ACON Laboratories, 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 |
|---|---|---|---|
| * | K132086 | ON Call Express Blood Glucose Monitoring SystemSummary page 4…System Predicate Device: On Call Express Blood Glucose Monitoring System ACON Laboratories Inc 10125 Mesa Rim Rd, San Diego, CA 92121 510(k) Number: K132086 Device Name: On Call Express Pro Blood Glucose Monitoring System 37 === Page… | 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 15 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 3 ancestors has a 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. 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 On Call Express Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm. The On Call Express Pro Blood Glucose Monitoring System is intended for multiple patient use by health care professionals in health care facilities as an aid to monitoring the effectiveness of diabetes control programs. The system should only be used with…
Read the full statement (194 words)
The On Call Express Pro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips, forearm and palm. The On Call Express Pro Blood Glucose Monitoring System is intended for multiple patient use by health care professionals in health care facilities as an aid to monitoring the effectiveness of diabetes control programs. The system should only be used with single-use, auto disabling lancing devices.
The On Call Express Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor intended for use on neonates. Alternative site testing (AST) testing should only be done during steady-state times (when glucose is not changing rapidly).
The On Call Express Pro Blood Glucose Test Strips are used with the On Call Express Pro Blood Glucose Meter in the quantitative measurement of glucose in capillary blood from the fingertips, forearm and palm.
The On Call Express Pro Blood Glucose Control Solution is for use with the On Call® Express Pro Blood Glucose Meter and Strips as a quality control check to verify the accuracy of blood glucose test results.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151595: On Call Express Pro 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/K151595
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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