510(k) · Cleared
Recalled · Class II · 2019Modification to Precision Xtra Advanced Diabetes Management System
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 15, 2004 as substantially equivalent to K983504 (Medisense, Inc., 1999) after a 16-day review. Its family tree reaches back 5 generations to 1995. 1 of the 28 devices in its family, counting itself, has a Class I recall. 16 later devices descend from it. It has been recalled 3 times.
- Decided
- Apr 15, 2004
- Review
- 16 days
- Class
- Class II
- Product code
- NBW
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 5 generations to K945887 (1995). 11 ancestors in all, the oldest K850368 (1985). 16 later devices descend from it, 3 citing it directly. 1 of the 28 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 4 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 3 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 2 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 1 generation backK983504 Precision Xtra Advanced Diabetes Management System, Precision Blood…Medisense, Inc. · 1999 · Recalled
- This deviceK040814 Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories · 2004
- Descendant · cites it directly · 10 of its ownK091547 Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max…Nova Biomedical Corp. · 2010 · Recalled (Class I)
- Descendant · cites it directly · 3 of its ownK080960 Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System…Abbott Diabetes Care, Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK161738 FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and…Taidoc Technology Corporation · 2016
- Descendant · 2 generations on · 2 of its ownK130094 Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring SystemAbbott Diabetes Care · 2013
- Descendant · 2 generations on · 1 of its ownK170463 KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood…I-Sens, Inc. · 2018
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K091547 Nova Max Plus Blood Glucose and B-Ketone Monitor…cites it directly · 2010
Most influential descendants
Showing 5 of 16 · See all- K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control…Nova Biomedical Corp. · 2010 · cites it directly10descendants
- K080960Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System with Models…Abbott Diabetes Care, Inc. · 2008 · cites it directly3descendants
- K161738FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring…Taidoc Technology Corporation · 2016 · 2 generations on2descendants
- K130094Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring SystemAbbott Diabetes Care · 2013 · 2 generations on2descendants
- K170463KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemI-Sens, Inc. · 2018 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −4 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −3 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −2 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −1 | K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose… | Medisense, Inc. | 1999 | 1 |
| 0 (this device) | K040814 | Modification to Precision Xtra Advanced Diabetes Management System | Abbott Laboratories | 2004 | — |
| +1 | K091547 | Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus… | Nova Biomedical Corp. | 2010 | Class I |
| +1 | K080960 | Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System with Models… | Abbott Diabetes Care, Inc. | 2008 | — |
| +2 | K161738 | FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone… | Taidoc Technology Corporation | 2016 | — |
| +2 | K130094 | Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System | Abbott Diabetes Care | 2013 | — |
| +2 | K170463 | KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone… | I-Sens, Inc. | 2018 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 1 |
| 2013 | 3 | 0 |
| 2016 | 2 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips…Summary page 1…tem Class I per 21 CFR 862.1435 Product Code: NBW, LFR, JIN Predicate Device: Precision Xtra mT Advanced Diabetes Management System, K983504 Description: The Precision XtraTM Advanced Diabetes Management System utilizes amperometric bios… | 1999 |
What descends from it? (16)
See all 163 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091547 | Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control… Class I | 2010 | 10 |
| K080960 | Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System with Models… | 2008 | 3 |
| K060768 | Precision Xtra Blood B Ketone Test Strips, Optium Blood B Ketone Test Strips | 2006 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 14, 2019 | Class II | Z-1556-2020 | 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… |
| Aug 2, 2007 | Not classified | Z-0112-2008 | Component design/selection | Damage could lead to no display. Meters manufactured after January 31, 2007 could exhibit meter display damage if dropped on a hard surface. These meters could exhibit unreadable lot number fields and date/time fields, in addition to… |
| Mar 5, 2007 | Not classified | Z-0856-2007 | Other | The front button covers may detach from the meter. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max…Nova Biomedical Corp. · 2010 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 110 Class I recalls
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K091547 (Nova Biomedical Corp., 2010) has gone furthest, with 10 descendants of its own.
- 5 other devices also cite its predicate K983504.
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 Advanced Diabetes Management System is intended for in vitro diagnostic use (i.e., external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The Precision Xtra is also intended for the quantitative measurement of f3-hydroxybutyrate (f3-ketone) in fresh capillary whole blood. The Precision Xtra system is indicated for home (lay user) or professional use in the management of Patients with diabetes.
The Precision Xtra System may also be used 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/K040814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040814: Modification to Precision Xtra Advanced Diabetes Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040814
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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