510(k) · Cleared
ClearedGluneo Blood Glucose Monitoring System, and Professional 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 31, 2013 as substantially equivalent to K062058 (Bayer Healthcare, 2006) after a 187-day review. Its family tree reaches back 1 generation to 2006. 6 later devices descend from it.
- Decided
- Jul 31, 2013
- Review
- 187 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K062058 (2006). 6 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK062058 Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip…Bayer Healthcare · 2006 · Recalled
- This deviceK130181 Gluneo Blood Glucose Monitoring System, and Professional Blood…Infopia Co, Ltd. · 2013
- Descendant · cites it directly · 4 of its ownK132966 Gluneo Lite Glucose Monitoring System, Gluneo Lite Professional…Infopia Co, Ltd. · 2013
- Descendant · 2 generations on · 1 of its ownK182286 Oh'Care Lite Smart Blood Glucose Monitoring SystemOsang Healthcare Co., Ltd. · 2018
- Descendant · 2 generations on · 0 of its ownK203562 Finetest Lite Blood Glucose Monitoring SystemOsang Healthcare Co., Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK201396 Finetest Lite Smart Blood Glucose Monitoring SystemOsang Healthcare Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK160365 BLE Smart Blood Glucose Monitoring System, BLE Smart Professional…Infopia Co, Ltd. · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K132966Gluneo Lite Glucose Monitoring System, Gluneo Lite Professional Blood Glucose Monitoring…Infopia Co, Ltd. · 2013 · cites it directly4descendants
- K182286Oh'Care Lite Smart Blood Glucose Monitoring SystemOsang Healthcare Co., Ltd. · 2018 · 2 generations on1descendant
- K203562Finetest Lite Blood Glucose Monitoring SystemOsang Healthcare Co., Ltd. · 2021 · 2 generations on0descendants
- K201396Finetest Lite Smart Blood Glucose Monitoring SystemOsang Healthcare Co., Ltd. · 2020 · 3 generations on0descendants
- K160365BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose…Infopia Co, Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K062058 | Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080 | Bayer Healthcare | 2006 | 2 |
| 0 (this device) | K130181 | Gluneo Blood Glucose Monitoring System, and Professional Blood Glucose… | Infopia Co, Ltd. | 2013 | — |
| +1 | K132966 | Gluneo Lite Glucose Monitoring System, Gluneo Lite Professional Blood Glucose… | Infopia Co, Ltd. | 2013 | — |
| +2 | K182286 | Oh'Care Lite Smart Blood Glucose Monitoring System | Osang Healthcare Co., Ltd. | 2018 | — |
| +2 | K203562 | Finetest Lite Blood Glucose Monitoring System | Osang Healthcare Co., Ltd. | 2021 | — |
| +3 | K201396 | Finetest Lite Smart Blood Glucose Monitoring System | Osang Healthcare Co., Ltd. | 2020 | — |
| +1 | K160365 | BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood… | Infopia Co, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K062058 | Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080Summary page 2…ion - GluNECT I GluNEGT Professional Blood Glucose Monitoring System 4. Predicate Device: Ascensia® CONTOUR Blood Glucose Monitoring System (K062058) by Bayer HealthCare, LLC. 5. Description: The GluNEO' M ' Blood Glucose Monitoring System consists… | 2006 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2013, 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 GluNEO™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The GluNEO™ Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The GluNEO™ Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people…
Read the full statement (491 words)
The GluNEO™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh. The GluNEO™ Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
The GluNEO™ Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It 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 GluNEO™ Test Strips are for use with the GluNEO™ Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood. Fresh capillary whole blood samples may be drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh.
The GluNEO™ Control Solutions are for use with the GluNEO™ Meter and GluNEO™ Test Strips to check that the meter and test strips are working together properly and the test is performing correctly.
The GlucoDiary is a PC-based software intended for use in home to help people with diabetes in the review, analysis and evaluation of glucose test results for effective diabetes management. It is intended for use as an accessory to GluNEO™ Blood Glucose Monitoring System.
The GluNEO™ Professional Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary whole blood from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and thigh and in venous whole blood. The GluNEO™ Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The GluNEO™ Professional 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 GluNEO™ Professional Test Strips are for use with the GluNEO™ Professional Meter to quantitatively measure glucose (sugar) in venous whole blood samples and fresh capillary whole blood samples drawn from the fingertips, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh.
The GluNEO™ Professional Control Solutions are for use with the GluNEO™ Professional Meter and GluNEO™ Professional Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The GlucoDiary is a PC-based software intended for use in professional settings to help healthcare professionals in the review, analysis and evaluation of their patients' glucose test results for effective diabetes management. It is intended for use as an accessory to GluNEO™ Professional Blood Glucose Monitoring System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130181 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130181: Gluneo Blood Glucose Monitoring System, and Professional 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/K130181
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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