510(k) · Cleared
ClearedPrecision Xtra Blood Glucose Test Strip with Truemeasure Technology
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 Jun 18, 2001 after a 112-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jun 18, 2001
- Review
- 112 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK010553 Precision Xtra Blood Glucose Test Strip with Truemeasure TechnologyAbbott Laboratories · 2001
- Descendant · cites it directly · 2 of its ownK023256 Precision Xtra/Medisense Optium/Precision Easy/Medisense Optium Easy…Abbott Laboratories · 2003
- Descendant · 2 generations on · 1 of its ownK051213 Precision Xtra Plus or Optium Plus, Blood Glucose Test StripsAbbott Laboratories, Inc. · 2005 · Recalled
- Descendant · 3 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 3 of 3 · See all- K023256Precision Xtra/Medisense Optium/Precision Easy/Medisense Optium Easy Blood Glucose Test…Abbott Laboratories · 2003 · cites it directly2descendants
- K051213Precision Xtra Plus or Optium Plus, Blood Glucose Test StripsAbbott Laboratories, Inc. · 2005 · 2 generations on1descendant
- K081975Relion Ultima Advance Blood Glucose Monitoring System Models, BGMS 71030-01 Strips…Abbott Diabetes Care, Inc. · 2008 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010553 | Precision Xtra Blood Glucose Test Strip with Truemeasure Technology | Abbott Laboratories | 2001 | — |
| +1 | K023256 | Precision Xtra/Medisense Optium/Precision Easy/Medisense Optium Easy Blood… | Abbott Laboratories | 2003 | — |
| +2 | K051213 | Precision Xtra Plus or Optium Plus, Blood Glucose Test Strips | Abbott Laboratories, Inc. | 2005 | 3 |
| +3 | 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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023256 | Precision Xtra/Medisense Optium/Precision Easy/Medisense Optium Easy Blood Glucose Test… | 2003 | 2 |
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, K023256 (Abbott Laboratories, 2003) has gone furthest, with 2 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 | — |
https://510kreport.com/device/K010553 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010553: Precision Xtra Blood Glucose Test Strip with Truemeasure Technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010553
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026