510(k) · Cleared
Recalled · 2005One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifescan, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Feb 7, 2003 after a 49-day review. The FDA summary names its predicate without a number. 83 later devices descend from it. It has been recalled 5 times.
- Decided
- Feb 7, 2003
- Review
- 49 days
- Class
- Class II
- Product code
- NBW
- Recalls
- 5
- Predicates
- 0
83 later devices descend from it, 15 citing it directly.
- This deviceK024194 One Touch Ultra and One Touch Induo Blood Glucose Monitoring SystemsLifescan, Inc. · 2003
- Descendant · cites it directly · 22 of its ownK080923 Caresens Blood Glucose Monitoring System; Caresens II Meter, Model…I-Sens, Inc. · 2008
- Descendant · cites it directly · 21 of its ownK083468 Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model…I-Sens, Inc. · 2009
- Descendant · cites it directly · 18 of its ownK042678 Rightest Blood Glucose Monitoring SystemBionime Corporation · 2005 · Recalled
- Descendant · 2 generations on · 17 of its ownK053635 Modification to Rightest Blood Glucose Monitoring SystemBionime Corporation · 2006 · Recalled
- Descendant · 2 generations on · 16 of its ownK062567 Rightest Blood Glucose Monitoring SystemBionime Corporation · 2007 · Recalled
Showing 5 of 83 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 83 · See all- K080923Caresens Blood Glucose Monitoring System; Caresens II Meter, Model GM505C; Caresens Pop…I-Sens, Inc. · 2008 · cites it directly22descendants
- K083468Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B…I-Sens, Inc. · 2009 · cites it directly21descendants
- K042678Rightest Blood Glucose Monitoring SystemBionime Corporation · 2005 · cites it directly18descendants
- K053635Modification to Rightest Blood Glucose Monitoring SystemBionime Corporation · 2006 · 2 generations on17descendants
- K062567Rightest Blood Glucose Monitoring SystemBionime Corporation · 2007 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K024194 | One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems | Lifescan, Inc. | 2003 | — |
| +1 | K080923 | Caresens Blood Glucose Monitoring System; Caresens II Meter, Model GM505C… | I-Sens, Inc. | 2008 | — |
| +1 | K083468 | Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or… | I-Sens, Inc. | 2009 | — |
| +1 | K042678 | Rightest Blood Glucose Monitoring System | Bionime Corporation | 2005 | 1 |
| +2 | K053635 | Modification to Rightest Blood Glucose Monitoring System | Bionime Corporation | 2006 | 1 |
| +2 | K062567 | Rightest Blood Glucose Monitoring System | Bionime Corporation | 2007 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 5 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 6 | 0 |
| 2010 | 6 | 0 |
| 2011 | 5 | 0 |
| 2012 | 10 | 0 |
| 2013 | 10 | 0 |
| 2014 | 5 | 0 |
| 2015 | 8 | 0 |
| 2016 | 4 | 0 |
| 2017 | 7 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | — | One Touch Ultra Blood Glucose Monitoring System Named without a submission number | |
| * | — | One Touch InDuo Blood Glucose Monitoring System Named without a submission number |
What descends from it? (83)
See all 8315 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080923 | Caresens Blood Glucose Monitoring System; Caresens II Meter, Model GM505C; Caresens Pop… | 2008 | 22 |
| K083468 | Caresens N Blood Glucose Monitoring System, Caresens N Meter, Model GM5051A or GM5051B… | 2009 | 21 |
| K042678 | Rightest Blood Glucose Monitoring System | 2005 | 18 |
| K073030 | AG-605 Blood Glucose Monitoring System | 2008 | 15 |
| K082683 | SD Check Gold | 2009 | 6 |
| K051285 | Glucolab Blood Glucose Monitoring System | 2005 | 6 |
| K082201 | G5 Infinity Blodo Glucose Monitoring System with Model Igm, 0024A | 2009 | 1 |
| K052469 | Glucopack | 2006 | 1 |
| K040012 | Well@Home System | 2004 | 1 |
| K061431 | Easygluco, Model Igm-0002 G2 | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 11, 2005 | Not classified | Z-0821-05 | Other | User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia. |
| Apr 11, 2005 | Not classified | Z-0822-05 | Other | User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia. |
| Apr 11, 2005 | Not classified | Z-0823-05 | Other | User may inadvertently change the Units of Measure from mg/dL to mmol/L and the blood glucose results could be misinterpreted. This may lead to under treatment and potential for hyperglycemia. |
| Nov 21, 2003 | Not classified | Z-1596-05 | Other | LifeScan brand OneTouch Ultra Meter - Owner's Booklets are missing instructions on how to set the Units of Measurement (UOM)--mg/dL versus mmol/L. This error has the potential to lead to acute hyperglycemic complications if the user fails… |
| Nov 17, 2003 | Not classified | Z-0887-05 | Other | A Control Solution range for the OneTouch Ultra Test Strip of 111-150 mg/dL was incorrectly labeled as 97-131 mg/dL. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K080923 (I-Sens, Inc., 2008) has gone furthest, with 22 descendants of its own.
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.
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 One Touch0 Ultra@ System is intended to be used for quantitative measurement of glucose in fresh capillary whole blood. The One Touch@ Ultra0 System is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor the effectiveness of diabetes control. The One Touch@InDuoTMBlood Glucose Meter is intended to be used for quantitative measurement of glucose in fresh capillary whole blood. The InDuoTM Blood Glucose…
Read the full statement (128 words)
The One Touch0 Ultra@ System is intended to be used for quantitative measurement of glucose in fresh capillary whole blood. The One Touch@ Ultra0 System is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor the effectiveness of diabetes control.
The One Touch@InDuoTMBlood Glucose Meter is intended to be used for quantitative measurement of glucose in fresh capillary whole blood. The InDuoTM Blood Glucose Meter is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor the effectiveness of diabetes control.
The One Touch@InDuoTMBlood Glucose Meter also functions as the cap for the InDuoTM Insulin Doser. The two devices fit together to form a single unit for user convenience.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024194: One Touch Ultra and One Touch Induo Blood Glucose Monitoring Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024194
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