510(k) · Cleared
ClearedWowGoHealth Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotest Medical Corporation · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Sep 15, 2017 as substantially equivalent to K141351 (Biotest Medical Corp., 2015) after a 92-day review. Its family tree reaches back 2 generations to 2007. 1 later device descends from it.
- Decided
- Sep 15, 2017
- Review
- 92 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K070585 (2007). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK070585 Accu-Chek Performa SystemRoche Diagnostics Corp. · 2007 · Recalled
- 1 generation backK141351 Supercheck Plus Blood Glucose Monitoring System, Super Check Plus…Biotest Medical Corp. · 2015
- This deviceK171785 WowGoHealth Blood Glucose Monitoring SystemBiotest Medical Corporation · 2017
- Descendant · cites it directly · 0 of its ownK213061 SuperCheck Pro Blood Glucose Monitoring SystemOk Biotech Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K213061SuperCheck Pro Blood Glucose Monitoring SystemOk Biotech Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K070585 | Accu-Chek Performa System | Roche Diagnostics Corp. | 2007 | 2 |
| −1 | K141351 | Supercheck Plus Blood Glucose Monitoring System, Super Check Plus Multi Blood… | Biotest Medical Corp. | 2015 | — |
| 0 (this device) | K171785 | WowGoHealth Blood Glucose Monitoring System | Biotest Medical Corporation | 2017 | — |
| +1 | K213061 | SuperCheck Pro Blood Glucose Monitoring System | Ok Biotech Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K141351 | Supercheck Plus Blood Glucose Monitoring System, Super Check Plus Multi Blood Glucose…Summary page 4…the Counter Predicate Device: 21 CFR 807.92(a)(3) Device Classification Name System, Test, Blood Glucose, Over The Counter 510(K) Number K141351 Device Name SuperCheck Plus Blood Glucose Monitoring System (Model 5228-S) Regulation Number… | 2015 |
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 |
|---|---|---|---|
| K213061 | SuperCheck Pro Blood Glucose Monitoring System | 2022 | 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 10 years and passes through 3 companies; a new generation was cleared every 8.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K213061 (Ok Biotech Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K141351.
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. 2017, 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 WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) consists of the WowGoHealth Blood Glucose Monitor and the WowGoHealth Blood Glucose Test Strip. The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or forearm. The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) is intended to be used by…
Read the full statement (152 words)
The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) consists of the WowGoHealth Blood Glucose Monitor and the WowGoHealth Blood Glucose Test Strip. The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips or forearm. The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) is intended to be used by a single person and should not be shared.
The WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) 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 WowGoHealth Blood Glucose Monitoring System (Model GSH-BGM902) 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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171785 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171785: WowGoHealth 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/K171785
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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