510(k) · Cleared
ClearedPro Glucose Test Strip
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 Dec 4, 2008 as substantially equivalent to K040796 (Roche Diagnostics Corp., 2004) after a 125-day review. Its family tree reaches back 2 generations to 2003. 10 later devices descend from it.
- Decided
- Dec 4, 2008
- Review
- 125 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K031755 (2003). 10 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK031755 Accu-Chek Compact Test StripRoche Diagnostics Corp. · 2003
- 1 generation backK040796 Accu-Chek GO SystemRoche Diagnostics Corp. · 2004 · Recalled
- This deviceK082169 Pro Glucose Test StripTaidoc Technology Corporation · 2008
- Descendant · cites it directly · 6 of its ownK100322 TD-4277 Blood Glucose Monitoring System, Model 4277Taidoc Technology Corporation · 2010
- Descendant · 2 generations on · 1 of its ownK190579 TD-4183 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2019
- Descendant · cites it directly · 1 of its ownK101259 V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002Taidoc Technology Corporation · 2010
- Descendant · 3 generations on · 0 of its ownK222126 VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart…Vivachek Biotech (Hangzhou) Co., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK181588 POPS! one Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2018
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K100322TD-4277 Blood Glucose Monitoring System, Model 4277Taidoc Technology Corporation · 2010 · cites it directly6descendants
- K190579TD-4183 Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2019 · 2 generations on1descendant
- K101259V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002Taidoc Technology Corporation · 2010 · cites it directly1descendant
- K222126VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose…Vivachek Biotech (Hangzhou) Co., Ltd. · 2024 · 3 generations on0descendants
- K181588POPS! one Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K031755 | Accu-Chek Compact Test Strip | Roche Diagnostics Corp. | 2003 | — |
| −1 | K040796 | Accu-Chek GO System | Roche Diagnostics Corp. | 2004 | 2 |
| 0 (this device) | K082169 | Pro Glucose Test Strip | Taidoc Technology Corporation | 2008 | — |
| +1 | K100322 | TD-4277 Blood Glucose Monitoring System, Model 4277 | Taidoc Technology Corporation | 2010 | — |
| +2 | K190579 | TD-4183 Blood Glucose Monitoring System | Taidoc Technology Corporation | 2019 | — |
| +1 | K101259 | V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002 | Taidoc Technology Corporation | 2010 | — |
| +3 | K222126 | VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood… | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024 | — |
| +2 | K181588 | POPS! one Blood Glucose Monitoring System | Taidoc Technology Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K040796 | Accu-Chek GO SystemSummary page 1…ietary Name: Accu-CheK Go Test System Common/Usual Name: Blood Glucose test system Manufacturer Roche Diagnostics 510 (k) Number K040796 iii Page 2-… | 2004 |
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K100322 (Taidoc Technology Corporation, 2010) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K040796.
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. 2008, 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 TaiDoc Pro I Glucose Test Strip is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. The test strips are for use with Clever Chek TD-4222, Clever Chek TD-4230, Clever Chek TD-4231 Blood Glucose Meters and Clever Chek TD-3250C, and Fora Comfort 2 in 1 TD-3260 Blood Glucose plus Blood Pressure…
Read the full statement (147 words)
The TaiDoc Pro I Glucose Test Strip is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, the upper-arm, the calf and the thigh. The test strips are for use with Clever Chek TD-4222, Clever Chek TD-4230, Clever Chek TD-4231 Blood Glucose Meters and Clever Chek TD-3250C, and Fora Comfort 2 in 1 TD-3260 Blood Glucose plus Blood Pressure Monitors Only.
It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Professionals may use the test strips to test capillary and venous blood samples, but lay user may not test venous blood samples.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082169: Pro Glucose Test Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082169
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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