510(k) Report

510(k) · Cleared

Recalled · 2009

Freestyle Lite Blood Glucose Monitoring System

K070850510(k) SpecialCleared Apr 10, 200713-day reviewClass II21 CFR 862.1345Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Abbott Diabetes Care, Inc. · NBW System, Test, Blood Glucose, Over The Counter

Cleared on Apr 10, 2007 as substantially equivalent to K051839 (Abbott Diabetes Care, Inc., 2006) after a 13-day review. Its family tree reaches back 8 generations to 1995. 1 of the 33 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it. It has been recalled once.

Decided
Apr 10, 2007
Review
13 days
Class
Class II
Product code
NBW
Recalls
1
Predicates
1

Its longest line of descent runs back 8 generations to K945887 (1995). 28 ancestors in all, the oldest K896951 (1990). 4 later devices descend from it, 2 citing it directly. 1 of the 33 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2001: 1 other ancestor2000: 3 other ancestors2002: 1 other ancestor1998: 3 other ancestors1997: 2 other ancestors1993: 1 other ancestor1996: 2 other ancestors1995: 3 other ancestors1992: 2 other ancestors1990: 1 other ancestor2010: 1 descendant cleared, 1 with a Class I recall12009: 1 descendant cleared2015: 2 descendants clearedK945887 · Precision Q I D Blood Glucose Test Strips · Medisense, Inc. · 1995K962295 · Precision Qid Blood Glucose Test Strip · Medisense, Inc. · 1996K963676 · Precision G Blood Glucose Testing System · Medisense, Inc. · 1997K971812 · Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip · Medisense, Inc. · 1997K982303 · Precision PCX Point of Care Management System , QC Manager Data Manager System, Precision G Plus Blood Glucose Test ST · Medisense, Inc. · 1998K022941 · Medisense Precision PCX Point of Care Management System for Blood Glucose Testing · Abbott Laboratories · 2002K050500 · Freestyle 600 Blood Glucose Monitoring System · Abbott Diabetes Care, Inc. · 2005K051839 · Free-Style Freedom Blood Glucose Monitoring System, Model 11001 · Abbott Diabetes Care, Inc. · 2006 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 4 other ancestors3 generations back: 7 other ancestors4 generations back: 4 other ancestors5 generations back: 2 other ancestors6 generations back: 3 other ancestors 1 generation forward: 2 descendants, 1 with a Class I recall12 generations forward: 2 descendants K051839 · Free-Style Freedom Blood Glucose Monitoring System, Model 11001 · Abbott Diabetes Care, Inc. · 2006 · recalledK050500 · Freestyle 600 Blood Glucose Monitoring System · Abbott Diabetes Care, Inc. · 2005K022941 · Medisense Precision PCX Point of Care Management System for Blood Glucose Testing · Abbott Laboratories · 2002K982303 · Precision PCX Point of Care Management System , QC Manager Data Manager System, Precision G Plus Blood Glucose Test ST · Medisense, Inc. · 1998K971812 · Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip · Medisense, Inc. · 1997K963676 · Precision G Blood Glucose Testing System · Medisense, Inc. · 1997K962295 · Precision Qid Blood Glucose Test Strip · Medisense, Inc. · 1996K945887 · Precision Q I D Blood Glucose Test Strips · Medisense, Inc. · 1995−50
  1. Root · 8 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
  2. 7 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
  3. 6 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
  4. 5 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
  5. 4 generations backK982303 Precision PCX Point of Care Management System , QC Manager Data…Medisense, Inc. · 1998
  6. 3 generations backK022941 Medisense Precision PCX Point of Care Management System for Blood…Abbott Laboratories · 2002
  7. 2 generations backK050500 Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2005
  8. 1 generation backK051839 Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc. · 2006 · Recalled
  9. This deviceK070850 Freestyle Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2007
  10. Descendant · cites it directly · 2 of its ownK092602 FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom…Abbott Diabetes Care, Inc. · 2010 · Recalled (Class I)
  11. Descendant · 2 generations on · 0 of its ownK150332 FreeStyle Lite Blood Glucose Monitoring SystemAbbott Laboratories · 2015
  12. Descendant · 2 generations on · 0 of its ownK150531 FreeStyle Freedom Lite Blood Glucose Monitoring SystemAbbott Laboratories · 2015
  13. Descendant · cites it directly · 0 of its ownK083225 Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2009

Class I recalls in this family

  • K092602 FREESTYLE Lite Blood Glucose Monitoring System…cites it directly · 2010

Most influential descendants

Showing 4 of 4 · See all
  • K092602FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose…Abbott Diabetes Care, Inc. · 2010 · cites it directly2descendants
  • K150332FreeStyle Lite Blood Glucose Monitoring SystemAbbott Laboratories · 2015 · 2 generations on0descendants
  • K150531FreeStyle Freedom Lite Blood Glucose Monitoring SystemAbbott Laboratories · 2015 · 2 generations on0descendants
  • K083225Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K945887Precision Q I D Blood Glucose Test StripsMedisense, Inc.1995—
−7K962295Precision Qid Blood Glucose Test StripMedisense, Inc.1996—
−6K963676Precision G Blood Glucose Testing SystemMedisense, Inc.1997—
−5K971812Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test StripMedisense, Inc.1997—
−4K982303Precision PCX Point of Care Management System , QC Manager Data Manager…Medisense, Inc.1998—
−3K022941Medisense Precision PCX Point of Care Management System for Blood Glucose…Abbott Laboratories2002—
−2K050500Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.2005—
−1K051839Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc.20062
0 (this device)K070850Freestyle Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.2007—
+1K092602FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite…Abbott Diabetes Care, Inc.2010Class I
+2K150332FreeStyle Lite Blood Glucose Monitoring SystemAbbott Laboratories2015—
+2K150531FreeStyle Freedom Lite Blood Glucose Monitoring SystemAbbott Laboratories2015—
+1K083225Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199220
199310
199530
199620
199720
199830
200030
200110
200210
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201011
201520
FIG. 1 — Lineage of K070850, 1995–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K051839Free-Style Freedom Blood Glucose Monitoring System, Model 11001
Summary page 1
…on Name: code NBW, LFR) FreeStyle FreedomTM Blood Glucose Monitoring Predicate Device: System (K051839) Description of the Device: The FreeStyle TM Lite Blood Glucose Monitoring System (BGMS) utilizes coulometric biosensor technol…
Abbott Diabetes Care, Inc.20062

Also cleared against K051839: 2 other devices →

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K092602FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose… Class IAbbott Diabetes Care, Inc.20102
K083225Freestyle Aviator Insulin Delivery and Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20090

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 10, 2009Not classifiedZ-1936-2009Process controlLow results: Freestyle Lite Blood Glucose Test strip may generate low blood glucose readings when tested with the control solution from lot 0822524 with Freestyle Freedom Lite and Freestyle Lite Blood Glucose Meters.

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 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

  • The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
  • 6 of the 28 ancestors have a recall of any class.
  • Of its descendants, K092602 (Abbott Diabetes Care, Inc., 2010) has gone furthest, with 2 descendants of its own.
  • 2 other devices also cite its predicate K051839.

How does its category compare?

All NBW devices

NBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · NBW

2in 2025

2007: 292008: 372009: 382010: 312011: 302012: 302013: 472014: 242015: 322016: 202017: 252018: 192019: 102020: 72021: 72022: 122023: 52024: 72025: 22026 (partial year): 5
2007high 47 (2013) · low 2 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NBW

243in 2024

2007: 85 days median2008: 128 days median2009: 140 days median2010: 132 days median2011: 328 days median2012: 230 days median2013: 167 days median2014: 202 days median2015: 237 days median2016: 233 days median2017: 244 days median2018: 168 days median2019: 127 days median2020: 121 days median2021: 465 days median2022: 410 days median2023: 193 days median2024: 243 days median2026 (partial year): 190 days median
2007high 465 (2021) · low 85 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NBW

1in 2025

2007: 92008: 22009: 52010: 112011: 12012: 12013: 5, 2 Class I2014: 12016: 12019: 142025: 1
2007high 14 (2019) · low 0 (2015)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · NBW

4,745in 2025

2007: 7,9912008: 7,7042009: 10,9632010: 11,6312011: 22,9092012: 23,4492013: 35,4082014: 38,5242015: 62,1112016: 76,6212017: 37,5382018: 16,9112019: 14,4722020: 10,7032021: 9,1982022: 8,1032023: 7,2562024: 6,2202025: 4,745
2007high 76,621 (2016) · low 4,745 (2025)2025

MAUDE reports naming product code NBW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007298597,991
20083712827,704
200938140510,963
2010311321111,631
201130328122,909
201230230123,449
2013471675 (2)35,408
201424202138,524
201532237062,111
201620233176,621
201725244037,538
201819168016,911
2019101271414,472
20207121010,703
2021746509,198
20221241008,103
2023519307,256
2024724306,220
20252—14,745
202651900—

What is it indicated for?

The FreeStyle TM Lite Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm, upper arm, thigh, calf and hand.

The FreeStyle TM Lite Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in whole blood. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates or arterial blood.

Indications for use as stated in the FDA summary.

Also cleared against K051839

2 other devices cite the same predicate.

  • K112638Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test StripsNova Biomedical Corporation · 2012
  • K092638Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22, 12101-23Abbott Diabetes Care, Inc. · 20102 Class I recalls

More from Abbott Diabetes Care, Inc.

152 FDA decisions under this applicant name. See the company

  • P150021/S061Freestyle Libre Pro Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2026
  • P160030/S058Freestyle Libre Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2026
  • P160030/S057FreeStyle Libre 14-Day Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2025
  • P150021/S060FreeStyle Libre Pro Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2025
  • K233537FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 20242 Class I recalls

Recent decisions in NBW

The NBW category page

  • K261293EASYMAX Voice Blood Glucose Monitoring SystemEPS Bio Technology Corp. · 2026
  • K260687VivaChek Blood Glucose and ß-Ketone Dual BLE Monitoring System;VivaChek Blood Glucose and ß-Ketone Dual…Vivachek Biotech (Hangzhou) Co., Ltd. · 2026
  • K260689CVS Advanced PLUS Blood Glucose Monitoring SystemI-Sens, Inc. · 2026
  • K260545CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System…Ascensia Diabetes Care · 2026
  • K262116TRUE METRIX Self Monitoring Blood Glucose SystemTrividia Health, Inc. · 2026

https://510kreport.com/device/K070850 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070850: 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/K070850

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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