510(k) · Cleared
ClearedEasy Plus II Blood Glucose Monitoring System,Easy Plus II Multi Blood Glucose Monitoring System,Smartest Persona II Bloo
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 Feb 21, 2014 as substantially equivalent to K100560 (Biotest Medical Corp., 2010) after a 99-day review. Its family tree reaches back 5 generations to 2004.
- Decided
- Feb 21, 2014
- Review
- 99 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K042005 (2004). No later device cites it as a predicate yet.
- Root · 5 generations backK042005 Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222Taidoc Technology Corporation · 2004
- 4 generations backK060467 Prodigy Blood Glucose Test SystemDiagnostic Devices, Inc. · 2006
- 3 generations backK073118 Prodigy Voice Blood Glucose Monitoring SystemDiagnostic Devices, Inc. · 2008
- 2 generations backK091815 Supercheck 1 Blood Glucose Monitoring System, Model 6268Biotest Medical Corp. · 2009
- 1 generation backK100560 Easy Talk Blood Glucose Monitoring System Model: 6277Biotest Medical Corp. · 2010
- This deviceK133509 Easy Plus II Blood Glucose Monitoring System,Easy Plus II Multi…Biotest Medical Corp. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K042005 | Achtung TD-4207, Clever Chek TD-4209, Clever Chek TD-4222 | Taidoc Technology Corporation | 2004 | — |
| −4 | K060467 | Prodigy Blood Glucose Test System | Diagnostic Devices, Inc. | 2006 | — |
| −3 | K073118 | Prodigy Voice Blood Glucose Monitoring System | Diagnostic Devices, Inc. | 2008 | — |
| −2 | K091815 | Supercheck 1 Blood Glucose Monitoring System, Model 6268 | Biotest Medical Corp. | 2009 | — |
| −1 | K100560 | Easy Talk Blood Glucose Monitoring System Model: 6277 | Biotest Medical Corp. | 2010 | — |
| 0 (this device) | K133509 | Easy Plus II Blood Glucose Monitoring System,Easy Plus II Multi Blood Glucose… | Biotest Medical Corp. | 2014 | — |
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 |
|---|---|---|---|
| * | K100560 | Easy Talk Blood Glucose Monitoring System Model: 6277Summary page 6…manuals were written to make the devices easy to use. 8. Conclusion Modifications to the cleared device, Easy Talk Blood Glucose Monitoring System, Model 6277 (K100560), include voice feature change from talking to, non-talking and housing design. In summary, the Easy Plus 11(6276-5), Easy Plus… | 2010 |
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 10 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 5 ancestors has a recall.
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. 2014, 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 Easy Plus 11 Blood Glucose Monitoring System Model 6276-S is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger and the forearm. The Easy Plus 11 Blood Glucose Monitoring System Model 6276-S is intended to be used by a single person and should not be shared. The Easy Plus 11 Blood Glucose Monitoring System Model 6276-S is intended for self-testing outside the body(in vitro diagnostic…
Read the full statement (824 words)
The Easy Plus 11 Blood Glucose Monitoring System Model 6276-S is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger and the forearm. The Easy Plus 11 Blood Glucose Monitoring System Model 6276-S is intended to be used by a single person and should not be shared. The Easy Plus 11 Blood Glucose Monitoring System Model 6276-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 Easy Plus 11 Blood Glucose Monitoring System Model 6276-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 Easy Plus 11 Test Strips are for use with the Easy Plus 11 Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the finger and the forearm.
The Easy Plus 11 Control Solutions are for use with the Easy Plus 11Blood Glucose Monitoring System Model 6276-S as a quality control check to verify that the meter and test strips are working together properly.
The Easy Plus 11 Multi Blood Glucose Monitoring System Model 6276-U is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger and the forearm. The Easy Plus 11Multi Blood Glucose Monitoring System Model 6276-M is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a profession healthcare setting as an aid to monitor the effectiveness of a diabetes control programi. This system should only be used with single-use, auto-disabling lancets. The Easy Plus 11 Multi Blood Glucose Monitoring System Model 6276-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 in not changing rapidly).
The Easy Plus 11 Multi Test Strips are for use with the Easy Plus 11 Blood Glucose Multi Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the finger and the forearm.
The Easy Plus 11 Multi Control Solutions are for use with the Easy Plus 11 Multi Blood Glucose Monitoring System Model 6276-M as aquality control check to verify that the meter and test strips are working together properly.
The Smartest Persona 11 Blood Glucose Monitoring System Model 6276-S is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger and the forearm. The Smartest Persona II Blood Glucose Monitoring System Model 6276-S is intended to be used by a single person and should not be shared. The Smartest Persona 11 Blood Glucose Monitoring System Model 6276-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. The Smartest Persona 11 Blood Glucose Monitoring System Model 6276-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 Smartest Persona 11 Test Strips are for use with the Smartest Persona 11 Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the finger and the forearm.
The Smartest Persona 11 Control Solutions are for use with the Smartest Persona 11Blood Glucose Monitoring System Model 6276-S asa quality control check to verify that the meter and test strips are working together properly.
The Smartest Persona 11 Multi Blood Glucose Monitoring System Model 6276-M is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the finger and the forearm. The Smartest Persona 11 Multi Blood Glucose Monitoring System Model 6276-M is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in a profession 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 Smartest Persona 11 Multi Blood Glucose Monitoring System Model 6276-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 in not changing rapidly).
The Smartest Persona 11 Multi Test Strips are for use with the Smartest Persona 11 Blood Glucose Multi Meter to quantitatively measure glucose in fresh capillary whole blood drawn from the finger and the forearm.
The Smartest Persona 11 Multi Control Solutions are for use with the Smartest Persona 11 Multi Blood Glucose Monitoring System Model 6276-M 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/K133509 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133509: Easy Plus II Blood Glucose Monitoring System,Easy Plus II Multi Blood Glucose Monitoring System,Smartest Persona II Bloo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133509
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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