510(k) Report

510(k) · Cleared

Cleared

Advocate Redi-Code Blood Glucose Monitoring System, Models TD-4223E; TD-4223F

K072039510(k) SpecialCleared Oct 3, 200770-day reviewClass II21 CFR 862.1345

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Taidoc Technology Corporation · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Oct 3, 2007 after a 70-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 4 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.

Decided
Oct 3, 2007
Review
70 days
Class
Class II
Product code
NBW
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2010: 1 descendant cleared2011: 1 descendant cleared2012: 1 descendant cleared, 1 with a Class I recall120052010201520202025
  1. This deviceK072039 Advocate Redi-Code Blood Glucose Monitoring System, Models TD-4223E…Taidoc Technology Corporation · 2007
  2. Descendant · cites it directly · 1 of its ownK102316 Glucose Shepherd Blood Glucose Monitoring SystemBroadmaster Biotech Corporation · 2011
  3. Descendant · 2 generations on · 0 of its ownK120183 Advocate Redi-Code+BMB-EA001S Blood Glucose Monitoring SystemBroadmaster Biotech Corperation · 2012 · Recalled (Class I)
  4. Descendant · cites it directly · 0 of its ownK093940 Advocate Redi-Code Dash Blood Glucose Monitoring System Model TD-4276Taidoc Technology Corporation · 2010

Class I recalls in this family

Most influential descendants

Showing 3 of 3 · See all
  • K102316Glucose Shepherd Blood Glucose Monitoring SystemBroadmaster Biotech Corporation · 2011 · cites it directly1descendant
  • K120183Advocate Redi-Code+BMB-EA001S Blood Glucose Monitoring SystemBroadmaster Biotech Corperation · 2012 · 2 generations on0descendants
  • K093940Advocate Redi-Code Dash Blood Glucose Monitoring System Model TD-4276Taidoc Technology Corporation · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K072039Advocate Redi-Code Blood Glucose Monitoring System, Models TD-4223E; TD-4223FTaidoc Technology Corporation2007—
+1K102316Glucose Shepherd Blood Glucose Monitoring SystemBroadmaster Biotech Corporation2011—
+2K120183Advocate Redi-Code+BMB-EA001S Blood Glucose Monitoring SystemBroadmaster Biotech Corperation2012Class I
+1K093940Advocate Redi-Code Dash Blood Glucose Monitoring System Model TD-4276Taidoc Technology Corporation2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201211
FIG. 1 — Lineage of K072039, 2007–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K102316Glucose Shepherd Blood Glucose Monitoring SystemBroadmaster Biotech Corporation20111
K093940Advocate Redi-Code Dash Blood Glucose Monitoring System Model TD-4276Taidoc Technology Corporation20100

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.

  • K120183Advocate Redi-Code+BMB-EA001S Blood Glucose Monitoring SystemBroadmaster Biotech Corperation · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K102316 (Broadmaster Biotech Corporation, 2011) has gone furthest, with 1 descendant of its own.

How does its category compare?

All NBW devices

NBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · NBW

2in 2025

2007: 292008: 372009: 382010: 312011: 302012: 302013: 472014: 242015: 322016: 202017: 252018: 192019: 102020: 72021: 72022: 122023: 52024: 72025: 22026 (partial year): 5
2007high 47 (2013) · low 2 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NBW

243in 2024

2007: 85 days median2008: 128 days median2009: 140 days median2010: 132 days median2011: 328 days median2012: 230 days median2013: 167 days median2014: 202 days median2015: 237 days median2016: 233 days median2017: 244 days median2018: 168 days median2019: 127 days median2020: 121 days median2021: 465 days median2022: 410 days median2023: 193 days median2024: 243 days median2026 (partial year): 190 days median
2007high 465 (2021) · low 85 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NBW

1in 2025

2007: 92008: 22009: 52010: 112011: 12012: 12013: 5, 2 Class I2014: 12016: 12019: 142025: 1
2007high 14 (2019) · low 0 (2015)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · NBW

4,745in 2025

2007: 7,9912008: 7,7042009: 10,9632010: 11,6312011: 22,9092012: 23,4492013: 35,4082014: 38,5242015: 62,1112016: 76,6212017: 37,5382018: 16,9112019: 14,4722020: 10,7032021: 9,1982022: 8,1032023: 7,2562024: 6,2202025: 4,745
2007high 76,621 (2016) · low 4,745 (2025)2025

MAUDE reports naming product code NBW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007298597,991
20083712827,704
200938140510,963
2010311321111,631
201130328122,909
201230230123,449
2013471675 (2)35,408
201424202138,524
201532237062,111
201620233176,621
201725244037,538
201819168016,911
2019101271414,472
20207121010,703
2021746509,198
20221241008,103
2023519307,256
2024724306,220
20252—14,745
202651900—
Cite this page

510(k) Report. “K072039: Advocate Redi-Code Blood Glucose Monitoring System, Models TD-4223E; TD-4223F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072039

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026