510(k) · Cleared
ClearedTyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyson Bioresearch, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Nov 29, 2018 as substantially equivalent to K170079 (Tyson Bioresearch, Inc., 2017) after a 121-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Nov 29, 2018
- Review
- 121 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K010362 (2001). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK010362 Accu-Chek Comfort Curve Test StripRoche Diagnostics Corp. · 2001 · Recalled
- 4 generations backK043474 Accu-Chek Aviva SystemRoche Diagnostics Corp. · 2005 · Recalled
- 3 generations backK121679 Accu-Chek Inform II Blood Glucose Monitoring SystemRoche Diagnostics · 2012 · Recalled
- 2 generations backK133741 ACCU-CHEK Performa Blood Glucose Monitoring SystemRoche Diagnostics · 2014 · Recalled
- 1 generation backK170079 Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B…Tyson Bioresearch, Inc. · 2017
- This deviceK182047 Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C…Tyson Bioresearch, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K010362 | Accu-Chek Comfort Curve Test Strip | Roche Diagnostics Corp. | 2001 | 6 |
| −4 | K043474 | Accu-Chek Aviva System | Roche Diagnostics Corp. | 2005 | 10 |
| −3 | K121679 | Accu-Chek Inform II Blood Glucose Monitoring System | Roche Diagnostics | 2012 | 3 |
| −2 | K133741 | ACCU-CHEK Performa Blood Glucose Monitoring System | Roche Diagnostics | 2014 | 1 |
| −1 | K170079 | Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood… | Tyson Bioresearch, Inc. | 2017 | — |
| 0 (this device) | K182047 | Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood… | Tyson Bioresearch, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K170079 | Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose…Summary page 6…designed, tested, and proven to work together as a system accurate blood glucose test results. Tyson Bio 50H Blood Glucose Test Strip (Test Strips are the same as k170079) and Tyson Bio 50H Control Solution (Control Solutions are the same as k170079) can be used with the Tyson Bio HT100-A Blood G… | 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 17 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 6 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K170079.
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 Tyson Bio HT100-A Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alterative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the…
Read the full statement (264 words)
The Tyson Bio HT100-A Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in
fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alterative site testing should be
performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro
diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of
diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis
of or screening for diabetes or for neonatal use.
The Tyson Bio HT100-A Blood Glucose Monitoring System is comprised of the Tyson Bio HT100-A Blood Glucose
Meter and Tyson Bio 50H Blood Glucose Test Strip.
The Tyson Bio HT100-C Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in
fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alterative site testing should be
performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro
diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of
diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis
of or screening for diabetes or for neonatal use.
The Tyson Bio HT100-C Blood Glucose Monitoring System is comprised of the Tyson Bio HT100-C Blood Glucose
Meter and Tyson Bio 50H Blood Glucose Test Strip.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182047 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182047: Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182047
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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