510(k) · Cleared
ClearedON Call Plus Diabetes Monitoring Software
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 Jan 7, 2011 as substantially equivalent to K091820 (Bayer Healthcare, 2009) after a 235-day review. Its family tree reaches back 1 generation to 2009. 1 later device descends from it.
- Decided
- Jan 7, 2011
- Review
- 235 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K091820 (2009). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK091820 Contour Usb Blood Glucose Meter, Glucose Test Strips; Glucofacts…Bayer Healthcare · 2009
- This deviceK101371 ON Call Plus Diabetes Monitoring SoftwareACON Laboratories, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK133584 IN Touch Blood Glucose Monitoring SystemEoshealth, Inc. · 2014 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K133584IN Touch Blood Glucose Monitoring SystemEoshealth, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K091820 | Contour Usb Blood Glucose Meter, Glucose Test Strips; Glucofacts Delux… | Bayer Healthcare | 2009 | — |
| 0 (this device) | K101371 | ON Call Plus Diabetes Monitoring Software | ACON Laboratories, Inc. | 2011 | — |
| +1 | K133584 | IN Touch Blood Glucose Monitoring System | Eoshealth, Inc. | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 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 |
|---|---|---|---|
| * | K091820 | Contour Usb Blood Glucose Meter, Glucose Test Strips; Glucofacts Delux Diabetes…Summary page 1…al use) Predicate Device: Glucofacts® Deluxe Diabetes Management Systems Bayer Healthcare 430 South Beiger Street, Mishawaka, IN 46544 5 10(k) K091820 -4- Device name: On Calle Plus Diabetes Monitoring Software Proprietary… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133584 | IN Touch Blood Glucose Monitoring System | 2014 | 0 |
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?
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. 2011, 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® Plus Diabetes Software is an optional software accessory to be used with the On Call® Plus Glucose Meter for transferring data to a computer and organizing it in tables and graphs to be used at home and by health care professionals. The software does not recommend any medical treatment or medication dosage level.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101371 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101371: ON Call Plus Diabetes Monitoring Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101371
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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