510(k) · Cleared
Recalled · Class II · 2019Relion Ultima Advance Blood Glucose Monitoring System Models, BGMS 71030-01 Strips: 7103-01 (20 Count)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Diabetes Care, Inc. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Nov 26, 2008 as substantially equivalent to K051213 (Abbott Laboratories, Inc., 2005) after a 138-day review. Its family tree reaches back 3 generations to 2001. It has been recalled 2 times.
- Decided
- Nov 26, 2008
- Review
- 138 days
- Class
- Class II
- Product code
- NBW
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010553 (2001). No later device cites it as a predicate yet.
- Root · 3 generations backK010553 Precision Xtra Blood Glucose Test Strip with Truemeasure TechnologyAbbott Laboratories · 2001
- 2 generations backK023256 Precision Xtra/Medisense Optium/Precision Easy/Medisense Optium Easy…Abbott Laboratories · 2003
- 1 generation backK051213 Precision Xtra Plus or Optium Plus, Blood Glucose Test StripsAbbott Laboratories, Inc. · 2005 · Recalled
- This deviceK081975 Relion Ultima Advance Blood Glucose Monitoring System Models, BGMS…Abbott Diabetes Care, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010553 | Precision Xtra Blood Glucose Test Strip with Truemeasure Technology | Abbott Laboratories | 2001 | — |
| −2 | 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 |
| 0 (this device) | K081975 | Relion Ultima Advance Blood Glucose Monitoring System Models, BGMS 71030-01… | Abbott Diabetes Care, Inc. | 2008 | — |
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 |
|---|---|---|---|
| * | K051213 | Precision Xtra Plus or Optium Plus, Blood Glucose Test StripsSummary page 2…n Ultima Advance Blood Glucose Monitoring System) and its predicate device, i.e. Optium Plus Blood Glucose Test Strips and Precision Xtra Plus Blood Glucose Test Strips (K051213) are indicated for home (lay user) or professional use. The modified ReliOn Ultima Advance Blood Glucose Monitoring System is su… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 14, 2019 | Class II | Z-1557-2020 | Labeling False and Misleading | Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instructions could lead… |
| Dec 22, 2010 | Not classified | Z-0995-2011 | Process control | Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
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. 2008, this device’s year, is highlighted.
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 ReliOn Ultima Advance Blood Glucose Monitoring System is intended for in-vitro diagnostic use in 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. It is not intended to be used for testing neonatal blood samples. The ReliOn Ultima Advance system is indicated for home (lay user) or professional use in the management of patients with diabetes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081975 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081975: Relion Ultima Advance Blood Glucose Monitoring System Models, BGMS 71030-01 Strips: 7103-01 (20 Count).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081975
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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