510(k) · Cleared
Recalled · Class II · 2021Modification to One Touch Ultra Blood Glucose Monitoring System
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 Aug 16, 2006 after a 15-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 6 times.
- Decided
- Aug 16, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- NBW
- Recalls
- 6
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK062195 Modification to One Touch Ultra Blood Glucose Monitoring SystemLifescan, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK110074 HL 568 Self Monitoring Blood Glucose System, HL 568BA…Health & Life Co., Ltd. · 2012
Most influential descendants
Showing 1 of 1 · See all- K110074HL 568 Self Monitoring Blood Glucose System, HL 568BA Self-Moniroting Blood Glucose SystemHealth & Life Co., Ltd. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K062195 | Modification to One Touch Ultra Blood Glucose Monitoring System | Lifescan, Inc. | 2006 | — |
| +1 | K110074 | HL 568 Self Monitoring Blood Glucose System, HL 568BA Self-Moniroting Blood… | Health & Life Co., Ltd. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (1)
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 Blood Glucose Monitoring System Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110074 | HL 568 Self Monitoring Blood Glucose System, HL 568BA Self-Moniroting Blood Glucose System | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 16, 2021 | Class II | Z-1938-2021 | Environmental control | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results. |
| Mar 16, 2021 | Class II | Z-1936-2021 | Environmental control | Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results. |
| Feb 25, 2013 | Class II | Z-1129-2013 | Nonconforming Material/Component | When OneTouch¿ Ultra and OneTouch¿ Select test strips are tested with Ultra and Select control solution the meter may display a result outside the control solution test range printed on the strip vial label even though the system is… |
| Jan 7, 2010 | Not classified | Z-2639-2010 | Mixed-up of materials/components | One Touch Ultra Test Strip products may actually contain a different product, One Touch Select strips. |
| Sep 19, 2008 | Not classified | Z-0004-2009 | Process control | Products exceed inaccuracy threshold , with many complaints resulting from inaccurate low results. |
| Mar 22, 2007 | Not classified | Z-1042-2007 | Other | Damaged Vials/Inaccurate test results: a manufacturing equipment problem on one of the packaging lines had the potential to puncture vials, causing a single hole in the side of the vial below the rim. This result of this defect may… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K110074 (Health & Life Co., Ltd., 2012) has gone furthest, with 0 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 OneTouch Ultra Blood Glucose Monitoring System is intended to be used
for the 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/or by 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, forearm or palm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062195 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062195: Modification to One Touch Ultra Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062195
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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