510(k) · Cleared
ClearedHealthpro Blood Glucose Monitoring System
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 Jul 13, 2012 as substantially equivalent to K091157 (Infopia Co, Ltd., 2009) after a 256-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Jul 13, 2012
- Review
- 256 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K942455 (1995). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK942455 Lifescan Surestep Blood Glucose Monitoring SystemLifescan, Inc. · 1995
- 3 generations backK984261 Surestep Blood Glucose Monitoring SystemLifescan, Inc. · 1999
- 2 generations backK051285 Glucolab Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2005
- 1 generation backK091157 Gluco Lab Auto Coding, Model Igm-0022Infopia Co, Ltd. · 2009
- This deviceK113192 Healthpro Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK132862 Healthpro Professional Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2013
Most influential descendants
Showing 1 of 1 · See all- K132862Healthpro Professional Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K942455 | Lifescan Surestep Blood Glucose Monitoring System | Lifescan, Inc. | 1995 | — |
| −3 | K984261 | Surestep Blood Glucose Monitoring System | Lifescan, Inc. | 1999 | — |
| −2 | K051285 | Glucolab Blood Glucose Monitoring System | Infopia Co, Ltd. | 2005 | — |
| −1 | K091157 | Gluco Lab Auto Coding, Model Igm-0022 | Infopia Co, Ltd. | 2009 | — |
| 0 (this device) | K113192 | Healthpro Blood Glucose Monitoring System | Infopia Co, Ltd. | 2012 | — |
| +1 | K132862 | Healthpro Professional Blood Glucose Monitoring System | Infopia Co, Ltd. | 2013 | — |
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 |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K091157 | Gluco Lab Auto Coding, Model Igm-0022Summary page 2…510k summary Page 1 of 3 510(k) Submission - Healthprom Blood Glucose Monitoring System K091 157 5. Description: The HealthproTM Blood Glucose Monitoring System consists of the meter, test strips and… | 2009 |
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 |
|---|---|---|---|
| K132862 | Healthpro Professional Blood Glucose Monitoring System | 2013 | 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 17 years and passes through 2 companies; a new generation was cleared every 4.3 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K132862 (Infopia Co, Ltd., 2013) has gone furthest, with 0 descendants 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. 2012, 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 Healthpro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh. The Healthpro Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The Healthpro Blood Glucose Monitoring System is intended for self-testing outside the…
Read the full statement (209 words)
The Healthpro Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh. The Healthpro Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
The Healthpro Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Healthpro Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).
The Healthpro test strips are for use with the Healthpro meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.
The Healthpro control solutions are for use with the Healthpro meter and test strips to check that the meter and test strips are working together properly and that the test as a quality control checks to verify the accuracy of blood glucose test results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113192: Healthpro 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/K113192
Report an extraction error
Are you the manufacturer?
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