510(k) Report

510(k) · Cleared

Cleared

One Touch Fasttake Compact Blood Glucose Monitoring System, One Touch Ultra Blood Glucose Monitoring System

K011479510(k) TraditionalCleared Nov 30, 2001200-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

Inverness Medical Innovations, Inc. · CGA Glucose Oxidase, Glucose

Cleared on Nov 30, 2001 after a 200-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided
Nov 30, 2001
Review
200 days
Class
Class II
Product code
CGA
Recalls
None
Predicates
0

6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2008: 2 descendants cleared2013: 2 descendants cleared2016: 1 descendant cleared200020052010201520202025
  1. This deviceK011479 One Touch Fasttake Compact Blood Glucose Monitoring System, One…Inverness Medical Innovations, Inc. · 2001
  2. Descendant · cites it directly · 5 of its ownK070506 SMS Multi Glucose Control, Model 2120049Medical Specialties Supply Co., Inc. · 2007
  3. Descendant · 2 generations on · 2 of its ownK081403 Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc. · 2008
  4. Descendant · 3 generations on · 1 of its ownK123851 Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc. · 2013
  5. Descendant · 2 generations on · 1 of its ownK082395 Glucose Meter-Check Control Solution for Bayer Ascensia Blood…Bionostics, Inc. · 2008
  6. Descendant · 4 generations on · 0 of its ownK152493 POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. · 2016

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22013: 22016: 1
2007high 2 (2008) · low 0 (2009)2026

Most influential descendants

Showing 5 of 6 · See all
  • K070506SMS Multi Glucose Control, Model 2120049Medical Specialties Supply Co., Inc. · 2007 · cites it directly5descendants
  • K081403Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc. · 2008 · 2 generations on2descendants
  • K123851Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc. · 2013 · 3 generations on1descendant
  • K082395Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter, Model: MC002Bionostics, Inc. · 2008 · 2 generations on1descendant
  • K152493POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc. · 2016 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011479One Touch Fasttake Compact Blood Glucose Monitoring System, One Touch Ultra…Inverness Medical Innovations, Inc.2001—
+1K070506SMS Multi Glucose Control, Model 2120049Medical Specialties Supply Co., Inc.2007—
+2K081403Glucose Meter-Check Control Solution for Roche Accu-ChekBionostics, Inc.2008—
+3K123851Glucose Meter-Check Solution for Roche Accu-ChekBionostics, Inc.2013—
+2K082395Glucose Meter-Check Control Solution for Bayer Ascensia Blood Glucose Meter…Bionostics, Inc.2008—
+4K152493POGO Automatic Blood Glucose Monitoring SystemIntuity Medical, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
201320
201610
FIG. 1 — Lineage of K011479, 2001–2016Source: 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.

Planning a device in CGA? 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 CGA device

  1. #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070506SMS Multi Glucose Control, Model 2120049Medical Specialties Supply Co., Inc.20075

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?

  • Of its descendants, K070506 (Medical Specialties Supply Co., Inc., 2007) has gone furthest, with 5 descendants of its own.

How does its category compare?

All CGA devices

CGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CGA

2in 2024

2007: 72008: 62009: 102010: 82011: 92012: 102013: 32014: 52015: 42016: 42017: 22018: 22019: 22020: 22021: 12022: 12023: 42024: 22026 (partial year): 1
2007high 10 (2009) · low 0 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CGA

249in 2023

2007: 122 days median2008: 56 days median2009: 155 days median2010: 122 days median2011: 217 days median2012: 123 days median2013: 441 days median2014: 265 days median2015: 150 days median2016: 157 days median2023: 249 days median
2007high 441 (2013) · low 56 (2008)2026

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

Recalls per year · CGA

3in 2023

2007: 22008: 22009: 42010: 62011: 32013: 32014: 22015: 6, 2 Class I2016: 22019: 12023: 3
2007high 6 (2010) · low 0 (2012)2026

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

Adverse event reports per year · CGA

59in 2025

2007: 292008: 372009: 752010: 1722011: 4232012: 2332013: 1722014: 1222015: 1552016: 362017: 922018: 692019: 1162020: 682021: 482022: 2722023: 1,1412024: 2662025: 59
2007high 1,141 (2023) · low 29 (2007)2025

MAUDE reports naming product code CGA, 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
20077122229
2008656237
200910155475
201081226172
201192173423
2012101230233
201334413172
201452652122
201541506 (2)155
20164157236
20172—092
20182—069
20192—1116
20202—068
20211—048
20221—0272
2023424931,141
20242—0266
20250—059
20261—0—

More from Inverness Medical Innovations, Inc.

6 FDA decisions under this applicant name. See the company

  • K071265Smartcheck Inr SystemInverness Medical Innovations, Inc. · 2007
  • K071587Ischemia Albumin Cobalt Binding Test (Acb Test) AssayInverness Medical Innovations, Inc. · 2007
  • K060133Ischemia Albumin Cobalt Binding Test (Acb) Assay Verification SetInverness Medical Innovations, Inc. · 2006
  • K053196Ischemia Albumin Cobalt Binding Test (Acb Test)Inverness Medical Innovations, Inc. · 2005
  • K011616Induo Blood Glucose MeterInverness Medical Innovations, Inc. · 2001

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https://510kreport.com/device/K011479 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011479: One Touch Fasttake Compact Blood Glucose Monitoring System, One Touch Ultra Blood Glucose 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/K011479

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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