510(k) · Cleared
ClearedFORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taidoc Technology Corporation · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Nov 10, 2016 as substantially equivalent to K091547 (Nova Biomedical Corp., 2010) after a 140-day review. Its family tree reaches back 7 generations to 1995. 1 of the 17 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it.
- Decided
- Nov 10, 2016
- Review
- 140 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K945887 (1995). 14 ancestors in all, the oldest K850368 (1985). 2 later devices descend from it, 2 citing it directly. 1 of the 17 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 6 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 5 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 4 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 3 generations backK983504 Precision Xtra Advanced Diabetes Management System, Precision Blood…Medisense, Inc. · 1999 · Recalled
- 2 generations backK040814 Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories · 2004 · Recalled
- 1 generation backK091547 Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max…Nova Biomedical Corp. · 2010 · Recalled (Class I)
- This deviceK161738 FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and…Taidoc Technology Corporation · 2016
- Descendant · cites it directly · 0 of its ownK201037 FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemTaidoc Technology Corporation · 2022
- Descendant · cites it directly · 0 of its ownK173345 TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring SystemTaidoc Technology Corporation · 2018
Class I recalls in this family
- K091547 Nova Max Plus Blood Glucose and B-Ketone Monitor…direct predicate · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −6 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −5 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −4 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −3 | K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose… | Medisense, Inc. | 1999 | 1 |
| −2 | K040814 | Modification to Precision Xtra Advanced Diabetes Management System | Abbott Laboratories | 2004 | 3 |
| −1 | K091547 | Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus… | Nova Biomedical Corp. | 2010 | Class I |
| 0 (this device) | K161738 | FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone… | Taidoc Technology Corporation | 2016 | — |
| +1 | K201037 | FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System | Taidoc Technology Corporation | 2022 | — |
| +1 | K173345 | TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System | Taidoc Technology Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K091547 | Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control…Summary page 8…CFR 862.1660 Quality control material (assayed and unassayed) 3. Predicate Device Nova Max Plus Blood Glucose and β-Ketone Monitor System (k091547) 4. Intended Use Single-patient use FORA ADVANCED GD40 Blood Glucose and β-Ketone Monitoring System is intended for the quant… | 2010 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max…Nova Biomedical Corp. · 2010 · Direct predicate · ◆ on the line of descent in FIG. 110 Class I recalls
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 14 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K201037 (Taidoc Technology Corporation, 2022) has gone furthest, with 0 descendants of its own.
- 6 other devices also cite its predicate K091547.
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. 2016, 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?
FORA ADVANCED GD40 Blood Glucose and ȕ-Ketone Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger, and for the quantitative measurement of ȕ-ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger. The FORA ADVANCED GD40 is intended for in vitro diagnostic use and is intended for single-patient use as an aid to monitor the effectiveness of a diabetes control…
Read the full statement (430 words)
FORA ADVANCED GD40 Blood Glucose and ȕ-Ketone Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger, and for the quantitative measurement of ȕ-ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger. The FORA ADVANCED GD40 is intended for in vitro diagnostic use and is intended for single-patient use as an aid to monitor the effectiveness of a diabetes control program. The system should not be used for the diagnosis of or screening for diabetes, nor for use on neonates.
FORA ADVANCED GD40 Blood Glucose Test Strips are for use with the FORA ADVANCED GD40 Blood Glucose and ȕ-Ketone Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the finger. The FORA ADVANCED GD40 Blood ȕ-Ketone Test Strips are for use with the FORA ADVANCED GD40 Blood Glucose and ȕ-Ketone Meter to quantitatively measure ȕ-ketone in fresh capillary whole blood samples drawn from the finger.
ȕ-Ketone Control Solutions are intended for use with FORA ADVANCED GD40 Blood Glucose and ȕ-Ketone Monitoring System to check that the meters and test strips are working together properly and that the test is performing correctly.
FORA ADVANCED GD40 pro Blood Glucose and ȕ-Ketone Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger, and from venous, and neonatal capillary heelstick whole blood, and for the quantitative measurement of ȕ-ketone (beta-hydroxybutyrate) in fresh capillary whole blood from the finger, and from venous whole blood. The FORA ADVANCED GD40 pro is intended for in vitro diagnostic use and is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices. The system should not be used for the diagnosis of or screening for diabetes.
FORA ADVANCED GD40 pro Blood Glucose Test Strips are for use with the FORA ADVANCED GD40 pro Blood Glucose and ȕ-Ketone Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertips, and from venous and neonatal whole blood. The FORA ADVANCED GD40 pro Blood ȕ-Ketone Test Strips are for use with the FORA ADVANCED GD40 pro Blood Glucose and ȕ-Ketone Meter to quantitatively measure ȕ-ketone in fresh capillary whole blood samples drawn from the fingertips and from venous whole blood.
ȕ-Ketone Control Solutions are intended for use with FORA ADVANCED GD40 Blood Glucose and ȕ-Ketone Monitoring System to check that the meters and test strips are working together properly and that the test is performing correctly.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161738 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161738: FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161738
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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