510(k) · Cleared
ClearedGlucopack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthpia America Corp. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Jun 5, 2006 as substantially equivalent to K024194 (Lifescan, Inc., 2003) and 2 other predicates after a 270-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Jun 5, 2006
- Review
- 270 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 deviceK052469 GlucopackHealthpia America Corp. · 2006
- Descendant · cites it directly · 0 of its ownK091168 Glucophone Blood Glucose Test System, Model Igm-0025Infopia Co, Ltd. · 2010
Most influential descendants
Showing 1 of 1 · See all- K091168Glucophone Blood Glucose Test System, Model Igm-0025Infopia Co, Ltd. · 2010 · 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) | K052469 | Glucopack | Healthpia America Corp. | 2006 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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? (4)
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…The FREEDOMTM Blood Glucose Monitoring System is substantially equivalent to the following predicate devices: K024194 - LifeScan, Inc. OneTouch® Ultra® K984261 - LifeScan, Inc. SURESTEP® K021513… | 2003 |
| * | K984261 | Surestep Blood Glucose Monitoring SystemSummary page 2…substantially equivalent to the following predicate devices: K024194 - LifeScan, Inc. OneTouch® Ultra® K984261 - LifeScan, Inc. SURESTEP® K021513 - Roche Diagnostics Corp. Accu-Chek Advantage Confidential… | 1999 |
| * | K021513 | Accu-Chek Advantage ModuleSummary page 2…icate devices: K024194 - LifeScan, Inc. OneTouch® Ultra® K984261 - LifeScan, Inc. SURESTEP® K021513 - Roche Diagnostics Corp. Accu-Chek Advantage Confidential Page 2… | 2002 |
| * | — | EasyGluco™ Named without a submission number |
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 |
|---|---|---|---|
| K091168 | Glucophone Blood Glucose Test System, Model Igm-0025 | 2010 | 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 11 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K091168 (Infopia Co, Ltd., 2010) 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.
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 GlucoPack Diabetes Monitoring' System is intended for use in the quantitative measurement of glucose in whole blood taken from the fingertip. Testing is done outside the body (in Vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes mellitus, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. It is not intended for use on neonates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052469 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052469: Glucopack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052469
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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