510(k) · Cleared
ClearedGlucophone Blood Glucose Test System, Model Igm-0025
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infopia Co, Ltd. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on May 27, 2010 as substantially equivalent to K052469 (Healthpia America Corp., 2006) and 1 other predicate after a 400-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- May 27, 2010
- Review
- 400 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K942455 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK942455 Lifescan Surestep Blood Glucose Monitoring SystemLifescan, Inc. · 1995
- 2 generations backK984261 Surestep Blood Glucose Monitoring SystemLifescan, Inc. · 1999
- 1 generation backK051285 Glucolab Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2005
- This deviceK091168 Glucophone Blood Glucose Test System, Model Igm-0025Infopia Co, Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K942455 | Lifescan Surestep Blood Glucose Monitoring System | Lifescan, Inc. | 1995 | — |
| −2 | K984261 | Surestep Blood Glucose Monitoring System | Lifescan, Inc. | 1999 | — |
| −1 | K051285 | Glucolab Blood Glucose Monitoring System | Infopia Co, Ltd. | 2005 | — |
| 0 (this device) | K091168 | Glucophone Blood Glucose Test System, Model Igm-0025 | Infopia Co, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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? (2)
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 |
|---|---|---|---|
| * | K052469 | GlucopackSummary page 1….1345, Product Code: NBW, CGA, JJX 3. Predicate Device: GlucoPackTm Blood Glucose Monitoring System(HealthPia America Corp.) K052469 GlucoLabTm Blood Glucose Monitoring System(Infopia co., Ltd.) K05 1285 Confidential Infopia Co., Ltd. === Page… | 2006 |
| * | K051285 | Glucolab Blood Glucose Monitoring SystemSummary page 1…e: GlucoPackTm Blood Glucose Monitoring System(HealthPia America Corp.) K052469 GlucoLabTm Blood Glucose Monitoring System(Infopia co., Ltd.) K05 1285 Confidential Infopia Co., Ltd. 510(k) for In Vitro Diagnostic Device 4.… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 15 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 7 ancestors have a recall of any class.
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. 2010, 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?
Glucophone TM Blood Glucose Testing System is for the quantitative measurement of the concentration of glucose in capillary whole blood that can be taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh by diabetic patients or healthcare professionals in the home and in clinical setting. GlucophoneTM Blood Glucose Testing System is for testing outside the body (in vitro diagnostic use only). GlucoPhoneTM Blood glucose Testing system is for use with a cellular phone. GlucoPhoneTM Blood glucose Testing system is not for neonatal use and not for diagnosis or screening of diabetes. Alternate site testing is for use during times of steady state.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091168 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091168: Glucophone Blood Glucose Test System, Model Igm-0025.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091168
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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