510(k) · Cleared
ClearedG5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U. S. Diagnostics, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Feb 20, 2009 as substantially equivalent to K024194 (Lifescan, Inc., 2003) and 2 other predicates after a 199-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Feb 20, 2009
- Review
- 199 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K942455 (1995). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK942455 Lifescan Surestep Blood Glucose Monitoring SystemLifescan, Inc. · 1995
- 1 generation backK984261 Surestep Blood Glucose Monitoring SystemLifescan, Inc. · 1999
- This deviceK082201 G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024AU. S. Diagnostics, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK110435 Easygluco Plus Blood Glucose Monitoring SystemU. S. Diagnostics, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K110435Easygluco Plus Blood Glucose Monitoring SystemU. S. Diagnostics, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942455 | Lifescan Surestep Blood Glucose Monitoring System | Lifescan, Inc. | 1995 | — |
| −1 | K984261 | Surestep Blood Glucose Monitoring System | Lifescan, Inc. | 1999 | — |
| 0 (this device) | K082201 | G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024A | U. S. Diagnostics, Inc. | 2009 | — |
| +1 | K110435 | Easygluco Plus Blood Glucose Monitoring System | U. S. Diagnostics, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (3)
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 |
|---|---|---|---|
| * | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsSummary page 2…nclusion: The Infinity TM Blood Glucose Monitoring System is substantially equivalent to the following predicate devices: K024194 - LifeScan, Inc. OneTouch® Ultra® K984261 - LifeScan, Inc. SURESTEP® K021513 - Roche Diag… | 2003 |
| * | K984261 | Surestep Blood Glucose Monitoring SystemSummary page 2…tem is substantially equivalent to the following predicate devices: K024194 - LifeScan, Inc. OneTouch® Ultra® K984261 - LifeScan, Inc. SURESTEP® K021513 - Roche Diagnostics Corp. Accu-Chek Advantage DEPART… | 1999 |
| * | K021513 | Accu-Chek Advantage ModuleSummary page 2…the following predicate devices: K024194 - LifeScan, Inc. OneTouch® Ultra® K984261 - LifeScan, Inc. SURESTEP® K021513 - Roche Diagnostics Corp. Accu-Chek Advantage DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2002 |
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 |
|---|---|---|---|
| K110435 | Easygluco Plus Blood Glucose Monitoring System | 2011 | 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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 9.8 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K110435 (U. S. Diagnostics, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 14 other devices also cite its predicate K024194.
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. 2009, 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 G5 Infinity TM Meter device is used along with the G5 Infinity TM Test Strips for the quantitative measurement of glucose'level in whole blood as an aid in monitoring.the. effectiveness of diabetes management in the home by patients-with diabetes'and in. clinical settings by healthcare professionals. G5 Infinity TM System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the dorsal palm, ventral palm, forearm, upper arm, calf and thigh. The G5 InfinityTM Blood Glucose Monitoring System is not intended for screening or diagnosis of diabetes and also not for use with neonates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082201: G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082201
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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