510(k) · Cleared
ClearedFinetest Lite Smart Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osang Healthcare Co., Ltd. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Oct 16, 2020 as substantially equivalent to K182286 (Osang Healthcare Co., Ltd., 2018) after a 141-day review. Its family tree reaches back 4 generations to 2006.
- Decided
- Oct 16, 2020
- Review
- 141 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K062058 (2006). No later device cites it as a predicate yet.
- Root · 4 generations backK062058 Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip…Bayer Healthcare · 2006 · Recalled
- 3 generations backK130181 Gluneo Blood Glucose Monitoring System, and Professional Blood…Infopia Co, Ltd. · 2013
- 2 generations backK132966 Gluneo Lite Glucose Monitoring System, Gluneo Lite Professional…Infopia Co, Ltd. · 2013
- 1 generation backK182286 Oh'Care Lite Smart Blood Glucose Monitoring SystemOsang Healthcare Co., Ltd. · 2018
- This deviceK201396 Finetest Lite Smart Blood Glucose Monitoring SystemOsang Healthcare Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K062058 | Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080 | Bayer Healthcare | 2006 | 2 |
| −3 | K130181 | Gluneo Blood Glucose Monitoring System, and Professional Blood Glucose… | Infopia Co, Ltd. | 2013 | — |
| −2 | K132966 | Gluneo Lite Glucose Monitoring System, Gluneo Lite Professional Blood Glucose… | Infopia Co, Ltd. | 2013 | — |
| −1 | K182286 | Oh'Care Lite Smart Blood Glucose Monitoring System | Osang Healthcare Co., Ltd. | 2018 | — |
| 0 (this device) | K201396 | Finetest Lite Smart Blood Glucose Monitoring System | Osang Healthcare Co., Ltd. | 2020 | — |
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 |
|---|---|---|---|
| * | K182286 | Oh'Care Lite Smart Blood Glucose Monitoring SystemSummary page 4…n regulation: 21 CFR Part 862.1345 ▪ Product Code: NBW 4. Predicate Device: Oh'Care Lite Smart Blood Glucose Monitoring System (K182286) by OSANG Healthcare Co., Ltd. 5. Description: The Finetest Lite Smart Blood Glucose Monitoring System cons… | 2018 |
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 14 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 4 ancestors has 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. 2020, 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 Finetest Lite Smart Blood Glucose Monitoring System is comprised of the Finetest Lite Smart meter and the Finetest Lite Smart Blood Glucose Test Strips. The Finetest Lite Smart 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 Finetest Lite Smart Blood Glucose Monitoring System is…
Read the full statement (197 words)
The Finetest Lite Smart Blood Glucose Monitoring System is comprised of the Finetest Lite Smart meter and the Finetest Lite Smart Blood Glucose Test Strips.
The Finetest Lite Smart 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 Finetest Lite Smart Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
The Finetest Lite Smart 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 Finetest Lite Smart Blood Glucose Test Strips are for use with the Finetest Lite Smart Meter to quantitatively measure glucose 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201396 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201396: Finetest Lite Smart Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201396
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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