510(k) · Cleared
ClearedFreestyle Auto-Assist Software Verson 2.0 with Model PRT24238-001
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 5, 2013 as substantially equivalent to K062770 (Abbott Diabetes Care, Inc., 2006) after a 186-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Apr 5, 2013
- Review
- 186 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K952279 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK952279 Precision Link Blood Glucose Data Management SystemMedisense, Inc. · 1995
- 2 generations backK040628 Precision Link Diabetes Data Management SystemAbbott Laboratories · 2004
- 1 generation backK062770 Copilot Health Management SystemAbbott Diabetes Care, Inc. · 2006
- This deviceK123089 Freestyle Auto-Assist Software Verson 2.0 with Model PRT24238-001Abbott Laboratories · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K952279 | Precision Link Blood Glucose Data Management System | Medisense, Inc. | 1995 | — |
| −2 | K040628 | Precision Link Diabetes Data Management System | Abbott Laboratories | 2004 | — |
| −1 | K062770 | Copilot Health Management System | Abbott Diabetes Care, Inc. | 2006 | — |
| 0 (this device) | K123089 | Freestyle Auto-Assist Software Verson 2.0 with Model PRT24238-001 | Abbott Laboratories | 2013 | — |
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 |
|---|---|---|---|
| * | K062770 | Copilot Health Management SystemSummary page 1…Code JQP) Predicate Device: CoPilotTM Health Management System Cleared under K062770 Legal Manufacturer: Abbott Diabetes Care Ltd R… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 3 companies; a new generation was cleared every 6.3 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K062770.
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 Auto-Assist Software Version 2.0 is intended for use by people with diabetes to aid in the review, analysis and evaluation of information such as blood glucose results, blood ketone test results and other data uploaded from a compatible meter, such as insulin doses and exercise data from the Freestyle lnsulinx meter, in support of an effective diabetes health management program.
Freestyle Auto-Assist software isnot intended for the diagnosis of or screening for diabetes mellitus
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123089 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123089: Freestyle Auto-Assist Software Verson 2.0 with Model PRT24238-001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123089
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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