510(k) Report

510(k) · Cleared

Cleared

One Touch Ultra Blood Glucose Monitoring System

K002134510(k) SpecialCleared Aug 7, 200024-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

Selfcare, Inc. · CGA Glucose Oxidase, Glucose

Cleared on Aug 7, 2000 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 73 later devices descend from it.

Decided
Aug 7, 2000
Review
24 days
Class
Class II
Product code
CGA
Recalls
None
Predicates
0

73 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2013: 5 descendants cleared2001: 2 descendants cleared2012: 6 descendants cleared2005: 1 descendant cleared2011: 3 descendants cleared2002: 3 descendants cleared2017: 3 descendants cleared2009: 6 descendants cleared2007: 1 descendant cleared2008: 5 descendants cleared2014: 4 descendants cleared2018: 2 descendants cleared2010: 1 descendant cleared2022: 6 descendants cleared2016: 4 descendants cleared2020: 3 descendants cleared2015: 2 descendants cleared2023: 4 descendants cleared2024: 4 descendants cleared2025: 5 descendants cleared2026: 3 descendants cleared200020052010201520202025
  1. This deviceK002134 One Touch Ultra Blood Glucose Monitoring SystemSelfcare, Inc. · 2000
  2. Descendant · cites it directly · 26 of its ownK021819 One Touch Ultrasmart Blood Glucose Monitoring SystemLifescan, Inc. · 2002 · Recalled
  3. Descendant · 2 generations on · 21 of its ownK072369 Evolution Blood Glucose Monitoring SystemHmd Biomedical, LLC · 2008
  4. Descendant · cites it directly · 17 of its ownK090057 ON-Call Plus Blood Glucose Monitoring SystemAcon Laboratories Co. · 2009
  5. Descendant · 2 generations on · 16 of its ownK113332 ON Call Chosen Lancing DeviceACON Laboratories, Inc. · 2012
  6. Descendant · 3 generations on · 10 of its ownK081703 Myglucohealth Glucose Monitoring SystemsEntra Health Systems, Ltd. · 2009

Showing 5 of 73 descendants. See all descendants

Descendants cleared per year

2001: 22002: 32005: 12007: 12008: 52009: 62010: 12011: 32012: 62013: 52014: 42015: 22016: 42017: 32018: 22020: 32022: 62023: 42024: 42025: 52026: 3
2001high 6 (2009) · low 0 (2003)2026

Most influential descendants

Showing 5 of 73 · See all
  • K021819One Touch Ultrasmart Blood Glucose Monitoring SystemLifescan, Inc. · 2002 · cites it directly26descendants
  • K072369Evolution Blood Glucose Monitoring SystemHmd Biomedical, LLC · 2008 · 2 generations on21descendants
  • K090057ON-Call Plus Blood Glucose Monitoring SystemAcon Laboratories Co. · 2009 · cites it directly17descendants
  • K113332ON Call Chosen Lancing DeviceACON Laboratories, Inc. · 2012 · 2 generations on16descendants
  • K081703Myglucohealth Glucose Monitoring SystemsEntra Health Systems, Ltd. · 2009 · 3 generations on10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002134One Touch Ultra Blood Glucose Monitoring SystemSelfcare, Inc.2000—
+1K021819One Touch Ultrasmart Blood Glucose Monitoring SystemLifescan, Inc.20021
+2K072369Evolution Blood Glucose Monitoring SystemHmd Biomedical, LLC2008—
+1K090057ON-Call Plus Blood Glucose Monitoring SystemAcon Laboratories Co.2009—
+2K113332ON Call Chosen Lancing DeviceACON Laboratories, Inc.2012—
+3K081703Myglucohealth Glucose Monitoring SystemsEntra Health Systems, Ltd.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200120
200230
200510
200710
200850
200960
201010
201130
201260
201350
201440
201520
201640
201730
201820
202030
202260
202340
202440
202550
202630
FIG. 1 — Lineage of K002134, 2000–2026Source: 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? (73)

See all 73

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

NumberDeviceApplicantDecidedDescendants
K021819One Touch Ultrasmart Blood Glucose Monitoring SystemLifescan, Inc.200226
K090057ON-Call Plus Blood Glucose Monitoring SystemAcon Laboratories Co.200917
K112653ON Call Vivid Blood Glucose Monitoring SystemsACON Laboratories, Inc.20127
K012324Accu-Chek Active Test SystemRoche Diagnostics Corp.20017
K160179VivaChek Ino Blood Glucose Monitoring SystemVivachek Laboratories, Inc.20174
K052108Sein Blood Glucose and Blood Pressure Monitor System, Model BGP-100Sein Electronics Co., Ltd.20052
K113636Blood Glucose Monitoring System (Glucose Oxidase)Philosys Co., Ltd.20130
K123010ON Call Vivid Blood Glucose Monitoring SystemACON Laboratories, Inc.20120
K111371ON Call Chosen Blood Glucose Monitoring SystemACON Laboratories, Inc.20110
K011616Induo Blood Glucose MeterInverness Medical Innovations, Inc.20010

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, K021819 (Lifescan, Inc., 2002) has gone furthest, with 26 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 Selfcare, Inc.

15 FDA decisions under this applicant name. See the company

  • K002867Inverness Medical Ovulation Predictor TestSelfcare, Inc. · 2000
  • K002049Inverness Medical Early Pregnancy TestSelfcare, Inc. · 2000
  • K001427Modification to Fasttake Compact Blood Glucose Monitoring SystemSelfcare, Inc. · 2000
  • K000583Fasttake Compact Blood Glucose Monitoring SystemSelfcare, Inc. · 2000
  • K993632Fasttake Compact Blood Glucose Monitoring SystemSelfcare, Inc. · 1999

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https://510kreport.com/device/K002134 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002134: 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/K002134

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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