510(k) · Cleared
ClearedFreestyle Precision Pro Blood Glucose and B-Ketone Monitoring System
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 Dec 24, 2013 as substantially equivalent to K130094 (Abbott Diabetes Care, 2013) after a 134-day review. Its family tree reaches back 8 generations to 1995. 1 later device descends from it.
- Decided
- Dec 24, 2013
- Review
- 134 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K945887 (1995). 14 ancestors in all, the oldest K850368 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 7 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 6 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 5 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 4 generations backK983504 Precision Xtra Advanced Diabetes Management System, Precision Blood…Medisense, Inc. · 1999 · Recalled
- 3 generations backK040814 Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories · 2004 · Recalled
- 2 generations backK080960 Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System…Abbott Diabetes Care, Inc. · 2008
- 1 generation backK130094 Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring SystemAbbott Diabetes Care · 2013
- This deviceK132511 Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring SystemAbbott Diabetes Care, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK153330 FreeStyle Precision Neo H Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K153330FreeStyle Precision Neo H Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −7 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −6 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −5 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −4 | K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose… | Medisense, Inc. | 1999 | 1 |
| −3 | K040814 | Modification to Precision Xtra Advanced Diabetes Management System | Abbott Laboratories | 2004 | 3 |
| −2 | 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 | — |
| 0 (this device) | K132511 | Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System | Abbott Diabetes Care, Inc. | 2013 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K130094 | Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring SystemSummary page 1…62.2 100), Product Code JQP Predicate Device Freestyle Precision Pro Blood Glucose and P-Ketone Monitoring System, cleared under k130094 Legal Manufacturer Abbott Diabetes Care. Inc. Range Road Witn… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153330 | FreeStyle Precision Neo H Blood Glucose Monitoring System | 2016 | 0 |
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 18 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K153330 (Abbott Diabetes Care, Inc., 2016) has gone furthest, with 0 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. 2013, 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 Freestyle Precision Pro Blood Glucose and O-Ketone Monitoring System is intended fir the quantitative measurement of glucose (sugar) in flresh capillary whole blood from the finger, and from venous, arterial and neonatal whole blood, and for the quantitative measurement of P- ketone (beta-hydroxybutyrate) in flesh capillary whole blood from the finger and venous, arterial, and neonatal whole blood when used within 30 minutes after collection. The…
Read the full statement (268 words)
The Freestyle Precision Pro Blood Glucose and O-Ketone Monitoring System is intended fir the quantitative measurement of glucose (sugar) in flresh capillary whole blood from the finger, and from venous, arterial and neonatal whole blood, and for the quantitative measurement of P- ketone (beta-hydroxybutyrate) in flesh capillary whole blood from the finger and venous, arterial, and neonatal whole blood when used within 30 minutes after collection. The Freestyle Precision Pro Blood Glucose and O-Ketone Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multiple-patient use in professional healthcare settings assa aid to monitor the effectiveness of a diabetes control program. This system should only be used with single-use, auto-disabling lancing devices. The system should not be used for the diagnosis of or screening for diabetes.
The Freestyle Precision Pro Blood Glucose Test Strips are for use with the Freestyle Precision Pro Blood Glucose and 1-Ketone Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn ftom the fingertips and from venous, arterial, and neonatal whole blood. The Freestyle Precision Pro Blood P-Ketone Test Strips are for use with the Freestyle Precision Pro Blood Glucose and P-Ketone Meter to quantitatively measure 0-ketone in fresh capillary whole blood samples drawn from the fingertips and from venous, arterial, and neonatal whole blood.
Freestyle Precision Pro Blood Glucose and I)-Ketone Monitoring System enables automatic transmission of stored data to a data management system using the docking station (optional), a data upload cable (optional), or wirelessly (optional) in a WiFi enabled facility when the meter and data management systems are properly configured.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K132511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132511: Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132511
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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