510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Microdot Xtra

K083273510(k) TraditionalCleared Nov 19, 2009378-day reviewClass II21 CFR 862.1345Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cambridge Sensors Limited · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Nov 19, 2009 as substantially equivalent to K070524 (Cambridge Sensors Limited, 2007) after a 378-day review. Its family tree reaches back 1 generation to 2007. 1 later device descends from it. It has been recalled once.

Decided
Nov 19, 2009
Review
378 days
Class
Class II
Product code
NBW
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K070524 (2007). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant clearedK070524 · Microdot Blood Glucose Monitoring System · Cambridge Sensors Limited · 200720052010201520202025
Descendants, by generation 1 generation forward: 1 descendant K070524 · Microdot Blood Glucose Monitoring System · Cambridge Sensors Limited · 20070
  1. Root · 1 generation backK070524 Microdot Blood Glucose Monitoring SystemCambridge Sensors Limited · 2007
  2. This deviceK083273 Microdot XtraCambridge Sensors Limited · 2009
  3. Descendant · cites it directly · 0 of its ownK102383 Microdot & Microdot XtraCambridge Sensors Limited · 2012

Most influential descendants

Showing 1 of 1 · See all
  • K102383Microdot & Microdot XtraCambridge Sensors Limited · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K070524Microdot Blood Glucose Monitoring SystemCambridge Sensors Limited2007—
0 (this device)K083273Microdot XtraCambridge Sensors Limited2009—
+1K102383Microdot & Microdot XtraCambridge Sensors Limited2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
FIG. 1 — Lineage of K083273, 2007–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K070524Microdot Blood Glucose Monitoring System
Summary page 3
…asure current generated on disposable test strips. The strip remains unchanged since the last submission approval, microdot®Blood Glucose Monitoring System (k070524). The Test Strip manufacturing and performance characteristics are unchanged. The test strips are designed to quantitativ…
Cambridge Sensors Limited2007—

Also cleared against K070524: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K102383Microdot & Microdot XtraCambridge Sensors Limited20120

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 26, 2018Class IIZ-2357-2019Nonconforming Material/ComponentThe firm reported that a faulty cutting/punching machine did not meet specifications after being fitted with new blades and did not correctly "notch" BG test strips intended for use in the US. The impacted strips did not fit into the…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K102383 (Cambridge Sensors Limited, 2012) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K070524.

How does its category compare?

All NBW devices

NBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · NBW

2in 2025

2007: 292008: 372009: 382010: 312011: 302012: 302013: 472014: 242015: 322016: 202017: 252018: 192019: 102020: 72021: 72022: 122023: 52024: 72025: 22026 (partial year): 5
2007high 47 (2013) · low 2 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NBW

243in 2024

2007: 85 days median2008: 128 days median2009: 140 days median2010: 132 days median2011: 328 days median2012: 230 days median2013: 167 days median2014: 202 days median2015: 237 days median2016: 233 days median2017: 244 days median2018: 168 days median2019: 127 days median2020: 121 days median2021: 465 days median2022: 410 days median2023: 193 days median2024: 243 days median2026 (partial year): 190 days median
2007high 465 (2021) · low 85 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NBW

1in 2025

2007: 92008: 22009: 52010: 112011: 12012: 12013: 5, 2 Class I2014: 12016: 12019: 142025: 1
2007high 14 (2019) · low 0 (2015)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · NBW

4,745in 2025

2007: 7,9912008: 7,7042009: 10,9632010: 11,6312011: 22,9092012: 23,4492013: 35,4082014: 38,5242015: 62,1112016: 76,6212017: 37,5382018: 16,9112019: 14,4722020: 10,7032021: 9,1982022: 8,1032023: 7,2562024: 6,2202025: 4,745
2007high 76,621 (2016) · low 4,745 (2025)2025

MAUDE reports naming product code NBW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007298597,991
20083712827,704
200938140510,963
2010311321111,631
201130328122,909
201230230123,449
2013471675 (2)35,408
201424202138,524
201532237062,111
201620233176,621
201725244037,538
201819168016,911
2019101271414,472
20207121010,703
2021746509,198
20221241008,103
2023519307,256
2024724306,220
20252—14,745
202651900—

What is it indicated for?

The microdot Xtra ®Blood Glucose Monitoring System is intended for self test use outside the body (in vitro diagnostic use only). It should be used only for testing fresh capillary whole blood samples from a fingerstick for glucose (sugar). It is not intended for use on neonates or in the diagnosis of or screening for diabetes mellitus. The microdotXtra ® Blood Glucose Monitoring System is intended for self testing of glucose in capillary whole blood…

Read the full statement (213 words)

The microdot Xtra ®Blood Glucose Monitoring System is intended for self test use outside the body (in vitro diagnostic use only). It should be used only for testing fresh capillary whole blood samples from a fingerstick for glucose (sugar). It is not intended for use on neonates or in the diagnosis of or screening for diabetes mellitus.

The microdotXtra ® Blood Glucose Monitoring System is intended for self testing of glucose in capillary whole blood from a fingerstick by persons with diabetes or by health care professionals in home settings or healthcare facilities.

The microdot Xtra ® 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.

The microdot Xtra ® 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.

The microdot®Control solutions are intended for use with microdot Xtra ® Blood Glucose Meter and microdot Xtra ® 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.

Also cleared against K070524

1 other device cites the same predicate.

  • K102383Microdot & Microdot XtraCambridge Sensors Limited · 2012

More from Cambridge Sensors Limited

3 FDA decisions under this applicant name. See the company

  • K102383Microdot & Microdot XtraCambridge Sensors Limited · 2012
  • K070524Microdot Blood Glucose Monitoring SystemCambridge Sensors Limited · 2007

Recent decisions in NBW

The NBW category page

  • K261293EASYMAX Voice Blood Glucose Monitoring SystemEPS Bio Technology Corp. · 2026
  • K260687VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual…Vivachek Biotech (Hangzhou) Co., Ltd. · 2026
  • K260689CVS Advanced PLUS Blood Glucose Monitoring SystemI-Sens, Inc. · 2026
  • K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System…Ascensia Diabetes Care · 2026
  • K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc. · 2026

https://510kreport.com/device/K083273 · printed Nov 6, 2026

Cite this page

510(k) Report. “K083273: Microdot Xtra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083273

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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