510(k) · Cleared
ClearedPrecision Xceed Pro Blood Glucose and B-Ketone Monitoring System with Models BGMS:70900-03, 70090-02, G3CH Strips
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 Sep 5, 2008 as substantially equivalent to K040814 (Abbott Laboratories, 2004) after a 155-day review. Its family tree reaches back 6 generations to 1995. 3 later devices descend from it.
- Decided
- Sep 5, 2008
- Review
- 155 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K945887 (1995). 12 ancestors in all, the oldest K850368 (1985). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 5 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 4 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 3 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 2 generations backK983504 Precision Xtra Advanced Diabetes Management System, Precision Blood…Medisense, Inc. · 1999 · Recalled
- 1 generation backK040814 Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories · 2004 · Recalled
- This deviceK080960 Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System…Abbott Diabetes Care, Inc. · 2008
- Descendant · cites it directly · 2 of its ownK130094 Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring SystemAbbott Diabetes Care · 2013
- Descendant · 2 generations on · 1 of its ownK132511 Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring SystemAbbott Diabetes Care, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK153330 FreeStyle Precision Neo H Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2016
Most influential descendants
Showing 3 of 3 · See all- K130094Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring SystemAbbott Diabetes Care · 2013 · cites it directly2descendants
- K132511Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring SystemAbbott Diabetes Care, Inc. · 2013 · 2 generations on1descendant
- K153330FreeStyle Precision Neo H Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −5 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −4 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −3 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −2 | K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose… | Medisense, Inc. | 1999 | 1 |
| −1 | K040814 | Modification to Precision Xtra Advanced Diabetes Management System | Abbott Laboratories | 2004 | 3 |
| 0 (this device) | K080960 | Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System with Models… | Abbott Diabetes Care, Inc. | 2008 | — |
| +1 | K130094 | Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System | Abbott Diabetes Care | 2013 | — |
| +2 | K132511 | Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System | Abbott Diabetes Care, Inc. | 2013 | — |
| +3 | K153330 | FreeStyle Precision Neo H Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K040814 | Modification to Precision Xtra Advanced Diabetes Management SystemSummary page 1…§862.1435) Product codes NBW, LFR, JIN Predicate Device: Precision Xtra Diabetes Monitoring System (K040814) Description of the Device: The Precision Xceed Pro Blood Glucose and j3-Ketone Monitoring System (BGKMS) utilizes amperometric… | 2004 |
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 |
|---|---|---|---|
| K130094 | Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System | 2013 | 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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 12 ancestors have a recall of any class.
- Of its descendants, K130094 (Abbott Diabetes Care, 2013) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K040814.
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 Precision Xceed Pro Blood Glucose and P-Ketone Monitoring System is intended for in vitro (outside the body) diagnostic use for the quantitative measurement of glucose (D-glucose) in fresh capillary whole blood (fingertip), and of O3-Ketone (beta - hydroxybutyrate) in fresh capillary whole blood samples. The Precision Xceed Pro System is for home (lay user) or professional use. The system is not for use in diagnosing diabetes mellitus, but is to be…
Read the full statement (119 words)
The Precision Xceed Pro Blood Glucose and P-Ketone Monitoring System is intended for in vitro (outside the body) diagnostic use for the quantitative measurement of glucose (D-glucose) in fresh capillary whole blood (fingertip), and of O3-Ketone (beta - hydroxybutyrate) in fresh capillary whole blood samples. The Precision Xceed Pro System is for home (lay user) or professional use. The system is not for use in diagnosing diabetes mellitus, but is to be used as an aid in monitoring the effectiveness of diabetes control programs.
Healthcare professionals may also use the product for the quantitative measurement of glucose in venous, arterial, or neonatal whole blood and ketone in venous blood, provided the sample is used within 30 minutes after collection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080960 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080960: Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System with Models BGMS:70900-03, 70090-02, G3CH Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080960
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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