510(k) · Cleared
ClearedON Call Sharp 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 Dec 20, 2013 as substantially equivalent to K112653 (ACON Laboratories, Inc., 2012) after a 318-day review. Its family tree reaches back 2 generations to 2000. 3 later devices descend from it.
- Decided
- Dec 20, 2013
- Review
- 318 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K002134 (2000). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK002134 One Touch Ultra Blood Glucose Monitoring SystemSelfcare, Inc. · 2000
- 1 generation backK112653 ON Call Vivid Blood Glucose Monitoring SystemsACON Laboratories, Inc. · 2012
- This deviceK130284 ON Call Sharp Blood Glucose Monitoring SystemACON Laboratories, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK181527 On Call Sure Blood Glucose Monitoring System, On Call Sure Sync…ACON Laboratories, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK193340 GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose…Microtech Medical, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK200277 Livongo Blood Glucose Monitoring System (BG1000)Livongo Health, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See all- K181527On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring…ACON Laboratories, Inc. · 2018 · cites it directly1descendant
- K193340GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring SystemMicrotech Medical, Inc. · 2020 · cites it directly0descendants
- K200277Livongo Blood Glucose Monitoring System (BG1000)Livongo Health, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002134 | One Touch Ultra Blood Glucose Monitoring System | Selfcare, Inc. | 2000 | — |
| −1 | K112653 | ON Call Vivid Blood Glucose Monitoring Systems | ACON Laboratories, Inc. | 2012 | — |
| 0 (this device) | K130284 | ON Call Sharp Blood Glucose Monitoring System | ACON Laboratories, Inc. | 2013 | — |
| +1 | K181527 | On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose… | ACON Laboratories, Inc. | 2018 | — |
| +1 | K193340 | GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose… | Microtech Medical, Inc. | 2020 | — |
| +2 | K200277 | Livongo Blood Glucose Monitoring System (BG1000) | Livongo Health, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2020 | 2 | 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 |
|---|---|---|---|
| * | K112653 | ON Call Vivid Blood Glucose Monitoring SystemsSummary page 1…em Predicate Device: On Call® Vivid Blood Glucose Monitoring System ACON Laboratories. Inc., located at W0125 Mesa Rim Road, CA 92121. USA. 510(k) Number: KI 112653 Device Name: On Call Sharp Blood Glucose Monitoring System Proprietary Name Product… | 2012 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 2 companies; a new generation was cleared every 11.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K181527 (ACON Laboratories, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K112653.
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. 2013, 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 Sharp 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 pal by people with diabetes at home as an aid in monitoring the effttivenicss of diabetes control programs. Alternative silo testing should be done only during steady-state times (when blood glucose level is not changing rapidly), The On Call Sharp Blood Glucose Monitoring…
Read the full statement (198 words)
The On Call Sharp 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 pal by people with diabetes at home as an aid in monitoring the effttivenicss of diabetes control programs. Alternative silo testing should be done only during steady-state times (when blood glucose level is not changing rapidly), The On Call Sharp Blood Glucose Monitoring System Is intended to be used by a single patient and should not be shared. It is for in vito diagnostic use only.
The On Call Sharp Blood Glucose Monitoring System In not intended for the diagnosis of or sunening for diabetes. nor Intended for use on neonates.
The On Call Sharp Blood Gluicse Test Strips are used with dhe On Call Sharp Blood Glucose Matr in the quantitative measurement of glucose in capillary blood from the fingertips, forearm anid palm."
The On Call Sharp Blood Glucose Control Solutions are for use with the On Call Sharp Blood Glucose Meter and On Call Sharp Blood Glucose Test Strips to check that thre ma'to and test strips ame working together properly end the test is performing correctly.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130284 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130284: ON Call Sharp 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/K130284
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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