510(k) · Cleared
ClearedSupercheck Plus Blood Glucose Monitoring System, Super Check Plus Multi Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotest Medical Corp. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on May 19, 2015 as substantially equivalent to K070585 (Roche Diagnostics Corp., 2007) after a 362-day review. Its family tree reaches back 1 generation to 2007. 3 later devices descend from it.
- Decided
- May 19, 2015
- Review
- 362 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K070585 (2007). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK070585 Accu-Chek Performa SystemRoche Diagnostics Corp. · 2007 · Recalled
- This deviceK141351 Supercheck Plus Blood Glucose Monitoring System, Super Check Plus…Biotest Medical Corp. · 2015
- Descendant · cites it directly · 1 of its ownK171785 WowGoHealth Blood Glucose Monitoring SystemBiotest Medical Corporation · 2017
- Descendant · 2 generations on · 0 of its ownK213061 SuperCheck Pro Blood Glucose Monitoring SystemOk Biotech Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK171822 NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)Biotest Medical Corporation · 2017
Most influential descendants
Showing 3 of 3 · See all- K171785WowGoHealth Blood Glucose Monitoring SystemBiotest Medical Corporation · 2017 · cites it directly1descendant
- K213061SuperCheck Pro Blood Glucose Monitoring SystemOk Biotech Co., Ltd. · 2022 · 2 generations on0descendants
- K171822NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352)Biotest Medical Corporation · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K070585 | Accu-Chek Performa System | Roche Diagnostics Corp. | 2007 | 2 |
| 0 (this device) | 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 | — |
| +2 | K213061 | SuperCheck Pro Blood Glucose Monitoring System | Ok Biotech Co., Ltd. | 2022 | — |
| +1 | K171822 | NuvoMed Wireless Blood Glucose Monitoring System (Model BGM-6/0352) | Biotest Medical Corporation | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K070585 | Accu-Chek Performa SystemSummary page 5…CU-CHEK Performa System Common Name Blood Glucose Test System Manufacturer Roche Diagnostics Corporation 510(k) Number K070585 4. Device Description The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) (also applicable to: SuperCheck Pl… | 2007 |
What descends from it? (3)
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. 2015, 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 Plus Multi Blood Glucose Monitoring System (Model 5228-M) is composed of the SuperCheck Plus Multi Test Strips and SuperCheck Plus Multi Blood Glucose Meter and is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from fingertips or forearm, or in venous whole blood. The SuperCheck Plus Multi Blood Glucose Monitoring System(Model 5228-M) is intended for testing outside the body (in vitro…
Read the full statement (419 words)
The SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) is composed of the SuperCheck Plus Multi Test Strips and SuperCheck Plus Multi Blood Glucose Meter and is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from fingertips or forearm, or in venous whole blood. The SuperCheck Plus Multi Blood Glucose Monitoring System(Model 5228-M) is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a professional healthcare setting as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancets.
The SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) 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 SuperCheck Plus Multi Test Strips are for use with the SuperCheck Plus Multi Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from fingertips or forearm, or in venous whole blood.
The SuperCheck Plus Multi Control Solutions are for use with the SuperCheck Plus Multi Blood Glucose Monitoring System (Model 5228-M) as a quality control check to verify that the meter and test strips are working together properly.
The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or forearm. The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) is intended to be used by a single person and should not be shared. The SuperCheck Plus Blood Glucose Monitoring System(Model 5228-S) is intended for self-testing outside the body(in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program. The SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) 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 in not changing rapidly).
The SuperCheck Plus Test Strips are for use with the SuperCheck Plus Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the fingertips or forearm.
The SuperCheck Plus Control Solutions are for use with the SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) as a quality control check to verify that the meter and test strips are working together properly.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141351: Supercheck Plus Blood Glucose Monitoring System, Super Check Plus Multi 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/K141351
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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