510(k) · Cleared
ClearedFreeStyle Precision Neo H Blood Glucose 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 Feb 19, 2016 as substantially equivalent to K132511 (Abbott Diabetes Care, Inc., 2013) after a 92-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Feb 19, 2016
- Review
- 92 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K945887 (1995). 15 ancestors in all, the oldest K850368 (1985). No later device cites it as a predicate yet.
- Root · 9 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 5 generations between
- 3 generations backK080960 Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System…Abbott Diabetes Care, Inc. · 2008
- 2 generations backK130094 Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring SystemAbbott Diabetes Care · 2013
- 1 generation backK132511 Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring SystemAbbott Diabetes Care, Inc. · 2013
- This deviceK153330 FreeStyle Precision Neo H Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2016
Show all 9 generations
- Root · 9 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 8 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 7 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 6 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 5 generations backK983504 Precision Xtra Advanced Diabetes Management System, Precision Blood…Medisense, Inc. · 1999 · Recalled
- 4 generations backK040814 Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories · 2004 · Recalled
- 3 generations backK080960 Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System…Abbott Diabetes Care, Inc. · 2008
- 2 generations backK130094 Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring SystemAbbott Diabetes Care · 2013
- 1 generation backK132511 Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring SystemAbbott Diabetes Care, Inc. · 2013
- This deviceK153330 FreeStyle Precision Neo H Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −8 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −7 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −6 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −5 | K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose… | Medisense, Inc. | 1999 | 1 |
| −4 | K040814 | Modification to Precision Xtra Advanced Diabetes Management System | Abbott Laboratories | 2004 | 3 |
| −3 | K080960 | Precision Xceed Pro Blood Glucose and B-Ketone Monitoring System with Models… | Abbott Diabetes Care, Inc. | 2008 | — |
| −2 | K130094 | Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System | Abbott Diabetes Care | 2013 | — |
| −1 | K132511 | Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring System | Abbott Diabetes Care, Inc. | 2013 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K132511 | Freestyle Precision Pro Blood Glucose and B-Ketone Monitoring SystemSummary page 4…Product codes: NBW, LFR FreeStyle Precision Pro Blood Glucose and Beta-Ketone Monitoring Predicate Device: System (k132511) Establishment: Abbott Diabetes Care Ltd. Legal Range Road Manufactur… | 2013 |
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 21 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 15 ancestors have a recall of any class.
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. 2016, 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 H Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger, and in venous and arterial whole blood. The Freestyle Precision Neo H Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor the effectiveness…
Read the full statement (143 words)
The Freestyle Precision Neo H Blood Glucose Monitoring System is intended for the quantitative measurement of glucose (sugar) in fresh capillary whole blood from the finger, and in venous and arterial whole blood.
The Freestyle Precision Neo H Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an 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 or for neonatal testing.
The Freestyle Precision Neo H Blood Glucose Test Strips are for use with the Freestyle Precision Neo H Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood from the finger, and from venous and arterial whole blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153330 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153330: FreeStyle Precision Neo H Blood Glucose 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/K153330
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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