510(k) · Cleared
Recalled · 2005Onetouch Ultra, Induo and Ultrasmart Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifescan, Inc. · CGA Glucose Oxidase, Glucose
Cleared on May 20, 2005 after a 183-day review. The FDA summary names its predicate without a number. 6 later devices descend from it. It has been recalled 3 times.
- Decided
- May 20, 2005
- Review
- 183 days
- Class
- Class II
- Product code
- CGA
- Recalls
- 3
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK043197 Onetouch Ultra, Induo and Ultrasmart Blood Glucose Monitoring SystemLifescan, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK080639 Symphony Glucose Management SystemAnimas Corp. · 2008 · Recalled
- Descendant · cites it directly · 2 of its ownK062555 Ebsensor Blood Glucose Monitoring System, Model EB-GVisgeneer, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK122181 Ebchek Blood Glucose Monitoring SystemVisgeneer, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK091765 Ebcarryon Blood Glucose Monitoring SystemVisgeneer, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK083225 Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2009
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K080639Symphony Glucose Management SystemAnimas Corp. · 2008 · cites it directly2descendants
- K062555Ebsensor Blood Glucose Monitoring System, Model EB-GVisgeneer, Inc. · 2006 · cites it directly2descendants
- K122181Ebchek Blood Glucose Monitoring SystemVisgeneer, Inc. · 2013 · 2 generations on0descendants
- K091765Ebcarryon Blood Glucose Monitoring SystemVisgeneer, Inc. · 2010 · 2 generations on0descendants
- K083225Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043197 | Onetouch Ultra, Induo and Ultrasmart Blood Glucose Monitoring System | Lifescan, Inc. | 2005 | — |
| +1 | K080639 | Symphony Glucose Management System | Animas Corp. | 2008 | 7 |
| +1 | K062555 | Ebsensor Blood Glucose Monitoring System, Model EB-G | Visgeneer, Inc. | 2006 | — |
| +2 | K122181 | Ebchek Blood Glucose Monitoring System | Visgeneer, Inc. | 2013 | — |
| +2 | K091765 | Ebcarryon Blood Glucose Monitoring System | Visgeneer, Inc. | 2010 | — |
| +2 | K083225 | Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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 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 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | — | OneTouch® Ultra® Test Strip Named without a submission number | |
| * | — | OneTouch® Ultra® Blood Glucose Monitoring System Named without a submission number | |
| * | — | OneTouch® InDuo® Blood Glucose Monitoring System Named without a submission number | |
| * | — | OneTouch® UltraSmart® Blood Glucose Monitoring System Named without a submission number |
What descends from it? (6)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 1, 2005 | Not classified | Z-0435-06 | Other | Product may be defective and may give low inaccurate glucose results. |
| Oct 19, 2005 | Not classified | Z-0273-06 | Other | Vials of OneTouch Ultra Test Strips marked with quantities of 25 per vial actually contain only 10 strips. |
| Oct 10, 2005 | Not classified | Z-0272-06 | Other | Users may inadvertently change units of measurement on demonstration kits of the OneTouch Ultra Blood Glucose Meters |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K080639 (Animas Corp., 2008) has gone furthest, with 2 descendants of its own.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The OneTouch® Ultra® Blood Glucose Monitoring System is intended to be used for quantitative measurement of glucose in fresh capillary whole blood. The OneTouch® Ultra® System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch® Ultra® Blood Glucose Monitoring System is specifically…
Read the full statement (295 words)
The OneTouch® Ultra® Blood Glucose Monitoring System is intended to be used for quantitative measurement of glucose in fresh capillary whole blood. The OneTouch® Ultra® System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch® Ultra® Blood Glucose Monitoring System is specifically indicated for use on the finger, arm or palm.
The OneTouch® InDuo® System is intended to be used for quantitative measurement the body of glucose in fresh capillary whole blood. The OneTouch® Ultra® System is intended for use outside (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch® InDuo® Blood Glucose Meter also functions as the cap for the InDuo® Insulin Doser. The two devices fit together to form a single unit for user convenience. The OneTouch InDuo® Blood Glucose Monitoring System is specifically indicated for use on the finger, arm or palm.
The OneTouch® UltraSmart® System is intended to be used for quantitative measurement of glucose in fresh capillary whole blood. The OneTouch® Ultra® System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch UltraSmart® Blood Glucose Monitoring System provides the user with electronic logbook functions that store data such as insulin and oral medicationa data port that enables the user to download electronic data to a personal computer. The OneTouch® UltraSmart® Smart Blood Glucose Monitoring System is specifically indicated for use on the finger, arm or palm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043197 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043197: Onetouch Ultra, Induo and Ultrasmart 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/K043197
Report an extraction error
Are you the manufacturer?
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