510(k) · Cleared
ClearedPrecision Xtra/Medisense Optium/Precision Easy/Medisense Optium Easy Blood Glucose Test Strip with True Measure Technolo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Apr 23, 2003 as substantially equivalent to K010553 (Abbott Laboratories, 2001) after a 205-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.
- Decided
- Apr 23, 2003
- Review
- 205 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010553 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK010553 Precision Xtra Blood Glucose Test Strip with Truemeasure TechnologyAbbott Laboratories · 2001
- This deviceK023256 Precision Xtra/Medisense Optium/Precision Easy/Medisense Optium Easy…Abbott Laboratories · 2003
- Descendant · cites it directly · 1 of its ownK051213 Precision Xtra Plus or Optium Plus, Blood Glucose Test StripsAbbott Laboratories, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 0 of its ownK081975 Relion Ultima Advance Blood Glucose Monitoring System Models, BGMS…Abbott Diabetes Care, Inc. · 2008 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010553 | Precision Xtra Blood Glucose Test Strip with Truemeasure Technology | Abbott Laboratories | 2001 | — |
| 0 (this device) | K023256 | Precision Xtra/Medisense Optium/Precision Easy/Medisense Optium Easy Blood… | Abbott Laboratories | 2003 | — |
| +1 | K051213 | Precision Xtra Plus or Optium Plus, Blood Glucose Test Strips | Abbott Laboratories, Inc. | 2005 | 3 |
| +2 | K081975 | Relion Ultima Advance Blood Glucose Monitoring System Models, BGMS 71030-01… | Abbott Diabetes Care, Inc. | 2008 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K010553 | Precision Xtra Blood Glucose Test Strip with Truemeasure Technology | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051213 | Precision Xtra Plus or Optium Plus, Blood Glucose Test Strips | 2005 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K051213 (Abbott Laboratories, Inc., 2005) has gone furthest, with 1 descendant 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 Precision Xtra / MediSense Optium / Precision Easy / MediSense Optium Easy Blood Glucose Test Strip is intended for outside-the-body (in-vitro diagnostic) use. The system is indicated for the quantitative measurement of glucose in fresh whole blood for self-testing by lay users (e.g., from the finger, forearm, upper arm or base of thumb), or by health care professionals. The test strip is to be used for monitoring blood glucose concentrations in persons with diabetes and other conditions;
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023256: Precision Xtra/Medisense Optium/Precision Easy/Medisense Optium Easy Blood Glucose Test Strip with True Measure Technolo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023256
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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