510(k) · Cleared
ClearedTysonbio MD100 Blood Glucse Monitoring ,Tysonbio MD100 Pro Blood Glucise 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 Aug 21, 2012 as substantially equivalent to K062058 (Bayer Healthcare, 2006) after a 323-day review. Its family tree reaches back 1 generation to 2006.
- Decided
- Aug 21, 2012
- Review
- 323 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K062058 (2006). No later device cites it as a predicate yet.
- Root · 1 generation backK062058 Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip…Bayer Healthcare · 2006 · Recalled
- This deviceK112916 Tysonbio MD100 Blood Glucse Monitoring ,Tysonbio MD100 Pro Blood…Tyson Bioresearch, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K062058 | Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080 | Bayer Healthcare | 2006 | 2 |
| 0 (this device) | K112916 | Tysonbio MD100 Blood Glucse Monitoring ,Tysonbio MD100 Pro Blood Glucise… | Tyson Bioresearch, Inc. | 2012 | — |
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 |
|---|---|---|---|
| * | K062058 | Ascensia Contour Blood Glucose Meter, Model 7151; Reagent Strip, Model 7080Summary page 3…ing glucose dehydrogenase. There has been no change to the fundamental scientific technology. 7. Predicate device Ascensia CONTOUR Blood Glucose Monitoring System (K062058) Predicate Device (K062058) Proposed Device Item… | 2006 |
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?
- Its one ancestor has a recall.
- 6 other devices also cite its predicate K062058.
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. 2012, 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 TysonBio MD100 Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary and venous whole blood samples. Capillary samples may be drawn from the fingertip, palm and forearm. The TysonBio MD100 Pro Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the…
Read the full statement (400 words)
The TysonBio MD100 Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary and venous whole blood samples. Capillary samples may be drawn from the fingertip, palm and forearm. The TysonBio MD100 Pro Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with auto-disabling, single-use lancing devices. The TysonBio MD100 Pro Blood Glucose Monitoring System 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 TysonBio MD100 Pro Blood Glucose Test Strips are for use with the TysonBio MD100 Pro Blood Glucose Meter to quantitatively measure glucose in venous whole blood sample and fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The TysonBio MD100 Control Solutions is for use on the TysonBio MD100 Pro Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.
The TysonBio MD100 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in capillary and venous whole blood samples. Capillary samples may be drawn from the fingertip, palm and forearm. The TysonBio MD100 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.
The TysonBio MD100 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The TysonBio MD100 Blood Glucose Monitoring System 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 TysonBio MD100 Test Strips are for use with the TysonBio MD100 Blood Glucose Meter to quantitatively measure glucose in venous whole blood sample and fresh capillary whole blood samples drawn from the fingertips, forearm or palm.
The TysonBio MD100 Control Solutions is for use on the TysonBio MD100 Blood Glucose Monitoring Systems to check that the meter and test strips are working together properly and providing accurate results.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112916 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112916: Tysonbio MD100 Blood Glucse Monitoring ,Tysonbio MD100 Pro Blood Glucise 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/K112916
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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