510(k) · Cleared
ClearedMicrodot Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cambridge Sensors Limited · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jun 22, 2007 after a 119-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Jun 22, 2007
- Review
- 119 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK070524 Microdot Blood Glucose Monitoring SystemCambridge Sensors Limited · 2007
- Descendant · cites it directly · 1 of its ownK083273 Microdot XtraCambridge Sensors Limited · 2009 · Recalled
- Descendant · cites it directly · 0 of its ownK102383 Microdot & Microdot XtraCambridge Sensors Limited · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070524 | Microdot Blood Glucose Monitoring System | Cambridge Sensors Limited | 2007 | — |
| +1 | K083273 | Microdot Xtra | Cambridge Sensors Limited | 2009 | 1 |
| +1 | K102383 | Microdot & Microdot Xtra | Cambridge Sensors Limited | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | — | LifeScan One Touch Ultra blood glucose testing system Named without a submission number |
What descends from it? (2)
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?
- Of its descendants, K083273 (Cambridge Sensors Limited, 2009) has gone furthest, with 1 descendant of its own.
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. 2007, 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?
microdot Blood Glucose Monitoring System The microdot Blood Glucose Monitoring System is intended for self testing of glucose in capillary whole blood by persons with diabetes or by health care professionals in home settings or healthcare facilities. It is intended for monitoring of blood glucose levels only. microdot Blood Glucose Meter The microdot Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole…
Read the full statement (190 words)
microdot Blood Glucose Monitoring System
The microdot Blood Glucose Monitoring System is intended for self testing of glucose in capillary whole blood by persons with diabetes or by health care professionals in home settings or healthcare facilities. It is intended for monitoring of blood glucose levels only.
microdot Blood Glucose Meter
The microdot Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick. It is intended for use by persons with diabetes or by health care professionals in home settings or healthcare facilities. It is intended for monitoring of blood glucose levels only.
microdot Test Strips
The microdot Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick. It is intended for use by persons with diabetes or by health care professionals in home settings or healthcare facilities. It is intended for monitoring of blood glucose levels only.
microdot Control solutions
The microdot Control solutions are intended for use with microdot Blood Glucose Meter and microdot Test Strips as a quality control check to verify the accuracy of the blood glucose test results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070524 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070524: Microdot Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070524
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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