510(k) · Cleared
ClearedFreestyle Precision Neo Blood Glucose: Monitoring System, Test Strips (50CT), Test Strips (100CT)
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 30, 2014 as substantially equivalent to K083223 (Abbott Diabetes Care, Inc., 2009) after a 228-day review. Its family tree reaches back 1 generation to 2009. 2 later devices descend from it.
- Decided
- Sep 30, 2014
- Review
- 228 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K083223 (2009). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK083223 Relion Ultima Blood Glucose Monitoring System, Models 70055-50…Abbott Diabetes Care, Inc. · 2009 · Recalled
- This deviceK140371 Freestyle Precision Neo Blood Glucose: Monitoring System, Test…Abbott Diabetes Care, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK171941 FreeStyle Precision Neo Blood Glucose Test StripsAbbott Diabetes Care, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK142928 FreeStyle Precision Neo Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K083223 | Relion Ultima Blood Glucose Monitoring System, Models 70055-50, Strips (20… | Abbott Diabetes Care, Inc. | 2009 | 1 |
| 0 (this device) | K140371 | Freestyle Precision Neo Blood Glucose: Monitoring System, Test Strips (50CT)… | Abbott Diabetes Care, Inc. | 2014 | — |
| +1 | K171941 | FreeStyle Precision Neo Blood Glucose Test Strips | Abbott Diabetes Care, Inc. | 2017 | — |
| +1 | K142928 | FreeStyle Precision Neo Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K083223 | Relion Ultima Blood Glucose Monitoring System, Models 70055-50, Strips (20 Count)…Summary page 4…I (21 CFR§ 862.1345) Classification Name: Product codes: NBW,LFR Predicate Device: ReliOn Ultima Blood Glucose Monitoring System (k083223) Establishment: Abbott Diabetes Care Ltd. Legal Manufacturer:… | 2009 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Its one ancestor has a recall.
- Of its descendants, K171941 (Abbott Diabetes Care, Inc., 2017) 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. 2014, 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 Neo Blood Glucose Monitoring System is for use outside the body only (in vitro diagnostic use) in the quantitative measurement of glucose in fresh whole blood for self-testing by lay users from the fingers. It is not intended to be used for testing neonatal blood samples or the diagnosis or screening of diabetes. The FreeStyle Precision Neo System is indicated for home (lay user) in the management of patients with diabetes. It is…
Read the full statement (123 words)
The FreeStyle Precision Neo Blood Glucose Monitoring System is for use outside the body only (in vitro diagnostic use)
in the quantitative measurement of glucose in fresh whole blood for self-testing by lay users from the fingers. It is not
intended to be used for testing neonatal blood samples or the diagnosis or screening of diabetes.
The FreeStyle Precision Neo System is indicated for home (lay user) in the management of patients with diabetes. It is
intended to be used by a single person and should not be shared.
The FreeStyle Precision Neo Blood Glucose Test Strips are for use with the FreeStyle Precision Neo Blood Glucose
Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140371 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140371: Freestyle Precision Neo Blood Glucose: Monitoring System, Test Strips (50CT), Test Strips (100CT).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140371
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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