510(k) · Cleared
ClearedSuperCheck Pro Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ok Biotech Co., Ltd. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Oct 7, 2022 as substantially equivalent to K171785 (Biotest Medical Corporation, 2017) after a 380-day review. Its family tree reaches back 3 generations to 2007.
- Decided
- Oct 7, 2022
- Review
- 380 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K070585 (2007). No later device cites it as a predicate yet.
- Root · 3 generations backK070585 Accu-Chek Performa SystemRoche Diagnostics Corp. · 2007 · Recalled
- 2 generations backK141351 Supercheck Plus Blood Glucose Monitoring System, Super Check Plus…Biotest Medical Corp. · 2015
- 1 generation backK171785 WowGoHealth Blood Glucose Monitoring SystemBiotest Medical Corporation · 2017
- This deviceK213061 SuperCheck Pro Blood Glucose Monitoring SystemOk Biotech Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K070585 | Accu-Chek Performa System | Roche Diagnostics Corp. | 2007 | 2 |
| −2 | K141351 | Supercheck Plus Blood Glucose Monitoring System, Super Check Plus Multi Blood… | Biotest Medical Corp. | 2015 | — |
| −1 | K171785 | WowGoHealth Blood Glucose Monitoring System | Biotest Medical Corporation | 2017 | — |
| 0 (this device) | K213061 | SuperCheck Pro Blood Glucose Monitoring System | Ok Biotech Co., Ltd. | 2022 | — |
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 |
|---|---|---|---|
| * | K171785 | WowGoHealth Blood Glucose Monitoring SystemSummary page 4…rmation Manufacturer Biotest Medical Corp. Device Name WowGoHealth Blood Glucose Monitoring System 510(k) Number k171785 IV. Indications for Use Section 05: 510(k) Summary… | 2017 |
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 15 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- 1 of the 3 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. 2022, 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 SuperCheck Pro Blood Glucose Monitoring System is comprised of the SuperCheck Pro Blood Glucose Meter and SuperCheck Pro Blood Glucose Test Strips. The SuperCheck Pro Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger, forearm, upper arm, calf, thigh, or palm. It is intended to be used by a single person and should not be shared. The SuperCheck Pro Blood…
Read the full statement (147 words)
The SuperCheck Pro Blood Glucose Monitoring System is comprised of the SuperCheck Pro Blood Glucose Meter and SuperCheck Pro Blood Glucose Test Strips.
The SuperCheck Pro Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger, forearm, upper arm, calf, thigh, or palm. It is intended to be used by a single person and should not be shared. The SuperCheck Pro Blood Glucose Monitoring System is for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program.
The SuperCheck Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor for use with neonates.
Alternative site testing should be done only during steady-state conditions (when blood glucose is not changing rapidly).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213061: SuperCheck Pro 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/K213061
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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