510(k) · Cleared
ClearedOnetouch Ultra 2 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 Jan 17, 2006 after a 29-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 34 later devices descend from it.
- Decided
- Jan 17, 2006
- Review
- 29 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
34 later devices descend from it, 6 citing it directly.
- This deviceK053529 Onetouch Ultra 2 Blood Glucose Monitoring SystemLifescan, Inc. · 2006
- Descendant · cites it directly · 15 of its ownK073231 Onetouch Ultralink Blood Glucose Monitoring SystemLifescan, Inc. · 2008
- Descendant · 2 generations on · 13 of its ownK110894 Contour Next Link Wireless Blood Glucose MeterBayer Healthcare · 2012
- Descendant · 3 generations on · 10 of its ownK121087 Contour Next Usb Blood Glucose Monitoring SystemBayer Healthcare · 2012
- Descendant · 4 generations on · 9 of its ownK150942 Contour Next USB Blood Glucose Monitoring SystemBayer Healthcare · 2015
- Descendant · cites it directly · 9 of its ownK093745 One Touch Verio Blood Glucose Monitoring SystemLifescan, Inc. · 2011
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K073231Onetouch Ultralink Blood Glucose Monitoring SystemLifescan, Inc. · 2008 · cites it directly15descendants
- K110894Contour Next Link Wireless Blood Glucose MeterBayer Healthcare · 2012 · 2 generations on13descendants
- K121087Contour Next Usb Blood Glucose Monitoring SystemBayer Healthcare · 2012 · 3 generations on10descendants
- K150942Contour Next USB Blood Glucose Monitoring SystemBayer Healthcare · 2015 · 4 generations on9descendants
- K093745One Touch Verio Blood Glucose Monitoring SystemLifescan, Inc. · 2011 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053529 | Onetouch Ultra 2 Blood Glucose Monitoring System | Lifescan, Inc. | 2006 | — |
| +1 | K073231 | Onetouch Ultralink Blood Glucose Monitoring System | Lifescan, Inc. | 2008 | — |
| +2 | K110894 | Contour Next Link Wireless Blood Glucose Meter | Bayer Healthcare | 2012 | — |
| +3 | K121087 | Contour Next Usb Blood Glucose Monitoring System | Bayer Healthcare | 2012 | — |
| +4 | K150942 | Contour Next USB Blood Glucose Monitoring System | Bayer Healthcare | 2015 | — |
| +1 | K093745 | One Touch Verio Blood Glucose Monitoring System | Lifescan, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2026 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K012197 | FDA’s K012197 is Powerheart Cardiac Rhythm Module Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
What descends from it? (34)
See all 346 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073231 | Onetouch Ultralink Blood Glucose Monitoring System | 2008 | 15 |
| K093745 | One Touch Verio Blood Glucose Monitoring System | 2011 | 9 |
| K111456 | Medisign Blood Glucose Monitoring System | 2012 | 2 |
| K080639 | Symphony Glucose Management System | 2008 | 2 |
| K123090 | GLB Benecheck Premium Glu Monitoring System | 2013 | 0 |
| K082513 | Onetouch Vita Blood Glucose Monitoring System | 2008 | 0 |
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, K073231 (Lifescan, Inc., 2008) has gone furthest, with 15 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 2 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch Ultra 2 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 2 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/K053529 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053529: Onetouch Ultra 2 Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053529
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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