510(k) · Cleared
ClearedOh'Care 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 Sep 19, 2018 as substantially equivalent to K132966 (Infopia Co, Ltd., 2013) after a 27-day review. Its family tree reaches back 3 generations to 2006. 1 later device descends from it.
- Decided
- Sep 19, 2018
- Review
- 27 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K062058 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK062058 Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip…Bayer Healthcare · 2006 · Recalled
- 2 generations backK130181 Gluneo Blood Glucose Monitoring System, and Professional Blood…Infopia Co, Ltd. · 2013
- 1 generation backK132966 Gluneo Lite Glucose Monitoring System, Gluneo Lite Professional…Infopia Co, Ltd. · 2013
- This deviceK182286 Oh'Care Lite Smart Blood Glucose Monitoring SystemOsang Healthcare Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK201396 Finetest Lite Smart Blood Glucose Monitoring SystemOsang Healthcare Co., Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- K201396Finetest Lite Smart Blood Glucose Monitoring SystemOsang Healthcare Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K062058 | Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080 | Bayer Healthcare | 2006 | 2 |
| −2 | 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 | — |
| 0 (this device) | K182286 | Oh'Care Lite Smart Blood Glucose Monitoring System | Osang Healthcare Co., Ltd. | 2018 | — |
| +1 | K201396 | Finetest Lite Smart Blood Glucose Monitoring System | Osang Healthcare Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K132966 | Gluneo Lite Glucose Monitoring System, Gluneo Lite Professional Blood Glucose Monitoring…Summary page 4…Blood Glucose Test System Classification regulation: 21 CFR Part 862.1345 Product Code: NBW 4. Predicate Device: K132966, GluNEO Lite Blood Glucose Monitoring System and GluNEO Lite Professional Blood Glucose Monitoring System 5. Descrip… | 2013 |
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 |
|---|---|---|---|
| K201396 | Finetest Lite Smart Blood Glucose Monitoring System | 2020 | 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 12 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K201396 (Osang Healthcare Co., Ltd., 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K132966.
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. 2018, 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 Oh’Care 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 Oh’Care Lite Smart Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The Oh’Care Lite Smart Blood Glucose Monitoring System is intended for testing outside the body (in…
Read the full statement (172 words)
The Oh’Care 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 Oh’Care Lite Smart Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared.
The Oh’Care 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 Oh’Care Lite Smart Blood Glucose Test Strips are for use with the Oh’Care 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 as stated in the FDA summary.
https://510kreport.com/device/K182286 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182286: Oh'Care Lite Smart Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182286
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