510(k) · Cleared
ClearedMedisense Precision PCX Point of Care Management System for Blood Glucose Testing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · LFR Glucose Dehydrogenase, Glucose
Cleared on Oct 28, 2002 as substantially equivalent to K982303 (Medisense, Inc., 1998) after a 55-day review. Its family tree reaches back 5 generations to 1995. 2 of the 24 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it.
- Decided
- Oct 28, 2002
- Review
- 55 days
- Class
- Class II
- Product code
- LFR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K945887 (1995). 10 ancestors in all, the oldest K896951 (1990). 13 later devices descend from it, 2 citing it directly. 2 of the 24 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 4 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- 3 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- 2 generations backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- 1 generation backK982303 Precision PCX Point of Care Management System , QC Manager Data…Medisense, Inc. · 1998
- This deviceK022941 Medisense Precision PCX Point of Care Management System for Blood…Abbott Laboratories · 2002
- Descendant · cites it directly · 12 of its ownK050500 Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2005
- Descendant · 2 generations on · 10 of its ownK051839 Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 4 of its ownK092638 Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01…Abbott Diabetes Care, Inc. · 2010 · Recalled (Class I)
- Descendant · 3 generations on · 4 of its ownK070850 Freestyle Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 3 of its ownK112638 Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test…Nova Biomedical Corporation · 2012
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K050500Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2005 · cites it directly12descendants
- K051839Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc. · 2006 · 2 generations on10descendants
- K092638Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22…Abbott Diabetes Care, Inc. · 2010 · 3 generations on4descendants
- K070850Freestyle Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2007 · 3 generations on4descendants
- K112638Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test StripsNova Biomedical Corporation · 2012 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −4 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| −3 | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| −2 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| −1 | K982303 | Precision PCX Point of Care Management System , QC Manager Data Manager… | Medisense, Inc. | 1998 | — |
| 0 (this device) | K022941 | Medisense Precision PCX Point of Care Management System for Blood Glucose… | Abbott Laboratories | 2002 | — |
| +1 | K050500 | Freestyle 600 Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2005 | — |
| +2 | K051839 | Free-Style Freedom Blood Glucose Monitoring System, Model 11001 | Abbott Diabetes Care, Inc. | 2006 | 2 |
| +3 | K092638 | Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21… | Abbott Diabetes Care, Inc. | 2010 | Class I |
| +3 | K070850 | Freestyle Lite Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2007 | 1 |
| +3 | K112638 | Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test Strips | Nova Biomedical Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 2 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 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.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K982303 | Precision PCX Point of Care Management System , QC Manager Data Manager System…Summary page 1…ng System Classification: Glucose Test System, Class I1 per 21 CFR 862.1345 Predicate Devices: Precision PCx Point of Care Management System for Blood Glucose Testing (K982303) that uses the MediSense blood glucose test strip cleared under K971812. Description: The Precision PCx Point of Care Managemen… | 1998 |
What descends from it? (13)
See all 132 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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.
- K092638Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22, 12101-23Abbott Diabetes Care, Inc. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K092602FREESTYLE Lite Blood Glucose Monitoring System and Freestyle Freedom Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2010 · 4 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K050500 (Abbott Diabetes Care, Inc., 2005) has gone furthest, with 12 descendants of its own.
How does its category compare?
All LFR devicesLFR Glucose Dehydrogenase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFR
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · LFR
161in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFR
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFR
827in 2025
MAUDE reports naming product code LFR, 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 | 1 | — | 3 | 23,819 |
| 2008 | 0 | — | 1 | 6,584 |
| 2009 | 1 | — | 4 | 10,823 |
| 2010 | 0 | — | 0 | 4,865 |
| 2011 | 6 | 296 | 1 | 3,802 |
| 2012 | 13 | 152 | 1 | 3,341 |
| 2013 | 3 | 212 | 0 | 3,821 |
| 2014 | 3 | 161 | 0 | 3,960 |
| 2015 | 1 | — | 0 | 3,366 |
| 2016 | 0 | — | 0 | 2,145 |
| 2017 | 0 | — | 0 | 103 |
| 2018 | 0 | — | 0 | 108 |
| 2019 | 0 | — | 0 | 108 |
| 2020 | 0 | — | 0 | 132 |
| 2021 | 0 | — | 0 | 164 |
| 2022 | 0 | — | 0 | 101 |
| 2023 | 0 | — | 0 | 103 |
| 2024 | 0 | — | 0 | 171 |
| 2025 | 0 | — | 0 | 827 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MediSense Precision PCx Point of Care Management System for Blood Glucose is intended for the in vitro diagnostic use (i.e. for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The MediSense Precision PCx Point of Care Management System is for home (lay user) or professional use. The PCx Point of Care Management System for Blood Glucose Testing is for monitoring blood glucose concentration in patients with diabetes mellitus or other conditions.
The product may also be used by healthcare professionals for the quantitative measurement of glucose in venous, arterial, or neonatal whole blood, provided that the sample is used within 30 minutes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K022941 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022941: Medisense Precision PCX Point of Care Management System for Blood Glucose Testing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022941
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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