510(k) · Cleared
ClearedFreeStyle Lite Blood Glucose Monitoring 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 Jun 5, 2015 as substantially equivalent to K092602 (Abbott Diabetes Care, Inc., 2010) after a 115-day review. Its family tree reaches back 10 generations to 1995. 1 of the 31 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 5, 2015
- Review
- 115 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K945887 (1995). 30 ancestors in all, the oldest K896951 (1990). No later device cites it as a predicate yet. 1 of the 31 devices in this family, counting this one, has a Class I recall.
- Root · 10 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 6 generations between
- 3 generations backK051839 Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc. · 2006 · Recalled
- 2 generations backK070850 Freestyle Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2007 · Recalled
- 1 generation backK092602 FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom…Abbott Diabetes Care, Inc. · 2010 · Recalled (Class I)
- This deviceK150332 FreeStyle Lite Blood Glucose Monitoring SystemAbbott Laboratories · 2015
Show all 10 generations
- Root · 10 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 9 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 8 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 7 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 6 generations backK982303 Precision PCX Point of Care Management System , QC Manager Data…Medisense, Inc. · 1998
- 5 generations backK022941 Medisense Precision PCX Point of Care Management System for Blood…Abbott Laboratories · 2002
- 4 generations backK050500 Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2005
- 3 generations backK051839 Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc. · 2006 · Recalled
- 2 generations backK070850 Freestyle Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2007 · Recalled
- 1 generation backK092602 FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom…Abbott Diabetes Care, Inc. · 2010 · Recalled (Class I)
- This deviceK150332 FreeStyle Lite Blood Glucose Monitoring SystemAbbott Laboratories · 2015
Class I recalls in this family
- K092602 FREESTYLE Lite Blood Glucose Monitoring System…direct predicate · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −9 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −8 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −7 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −6 | K982303 | Precision PCX Point of Care Management System , QC Manager Data Manager… | Medisense, Inc. | 1998 | — |
| −5 | K022941 | Medisense Precision PCX Point of Care Management System for Blood Glucose… | Abbott Laboratories | 2002 | — |
| −4 | K050500 | Freestyle 600 Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2005 | — |
| −3 | K051839 | Free-Style Freedom Blood Glucose Monitoring System, Model 11001 | Abbott Diabetes Care, Inc. | 2006 | 2 |
| −2 | K070850 | Freestyle Lite Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2007 | 1 |
| −1 | K092602 | FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite… | Abbott Diabetes Care, Inc. | 2010 | Class I |
| 0 (this device) | K150332 | FreeStyle Lite Blood Glucose Monitoring System | Abbott Laboratories | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 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.
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 |
|---|---|---|---|
| * | K092602 | FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose…Summary page 4…ass II (21 CFR§ 862.1345) Classification Name: Product codes: NBW,LFR Predicate Device: FreeStyle Lite Blood Glucose Test Strips (k092602) Establishment: Abbott Diabetes Care Inc. Legal Manufacturer:… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K092602FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2010 · Direct predicate · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 30 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K092602.
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. 2015, 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 Lite Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program by quantitatively measuring glucose in fresh whole blood from the finger, upper arm and palm. The FreeStyle Lite Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.…
Read the full statement (142 words)
The FreeStyle Lite Blood Glucose Monitoring System is intended for self-testing outside the body (in vitro diagnostic use)
by people with diabetes at home as an aid in monitoring the effectiveness of a diabetes control program by quantitatively
measuring glucose in fresh whole blood from the finger, upper arm and palm. The FreeStyle Lite Blood Glucose
Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. It is intended to be
used by a single person and should not be shared. Alternate site testing should be done only during steady state times
(when glucose is not changing rapidly). The FreeStyle Lite Blood Glucose Test Strips are for use with the FreeStyle Lite
Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the
fingertips, upper arm and palm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150332: FreeStyle Lite 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/K150332
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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