510(k) Report

510(k) · Cleared

Cleared

Precision PCX Point of Care Management System , QC Manager Data Manager System, Precision G Plus Blood Glucose Test ST

K982303510(k) TraditionalCleared Dec 8, 1998160-day reviewClass II21 CFR 862.1345

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

Medisense, Inc. · CGA Glucose Oxidase, Glucose

Cleared on Dec 8, 1998 as substantially equivalent to K963676 (Medisense, Inc., 1997) and 5 other predicates after a 160-day review. Its family tree reaches back 4 generations to 1995. 2 of the 24 devices in its family, counting itself, have a Class I recall. 14 later devices descend from it.

Decided
Dec 8, 1998
Review
160 days
Class
Class II
Product code
CGA
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K945887 (1995). 9 ancestors in all, the oldest K896951 (1990). 14 later devices descend from it, 1 citing it directly. 2 of the 24 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1995: 2 other ancestors1996: 1 other ancestor1990: 1 other ancestor2002: 1 descendant cleared2005: 2 descendants cleared2006: 1 descendant cleared2010: 2 descendants cleared, 2 with a Class I recall22012: 2 descendants cleared2007: 1 descendant cleared2009: 1 descendant cleared2013: 2 descendants 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. · 19971990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 3 descendants, 1 with a Class I recall15 generations forward: 4 descendants, 1 with a Class I recall16 generations forward: 3 descendants K971812 · 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. · 19950+5
  1. Root · 4 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
  2. 3 generations backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
  3. 2 generations backK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
  4. 1 generation backK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
  5. This deviceK982303 Precision PCX Point of Care Management System , QC Manager Data…Medisense, Inc. · 1998
  6. Descendant · cites it directly · 13 of its ownK022941 Medisense Precision PCX Point of Care Management System for Blood…Abbott Laboratories · 2002
  7. Descendant · 2 generations on · 12 of its ownK050500 Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2005
  8. Descendant · 3 generations on · 10 of its ownK051839 Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc. · 2006 · Recalled
  9. Descendant · 4 generations on · 4 of its ownK092638 Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01…Abbott Diabetes Care, Inc. · 2010 · Recalled (Class I)
  10. Descendant · 4 generations on · 4 of its ownK070850 Freestyle Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2007 · Recalled

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2002: 12005: 22006: 12007: 12009: 12010: 22012: 22013: 22015: 2
2002high 2 (2005) · low 0 (2003)2026

Class I recalls in this family

  • K092638 Freestyle Blood Glucose Test Strips, Models…4 generations on · 2010
  • K092602 FREESTYLE Lite Blood Glucose Monitoring System…5 generations on · 2010

Most influential descendants

Showing 5 of 14 · See all
  • K022941Medisense Precision PCX Point of Care Management System for Blood Glucose TestingAbbott Laboratories · 2002 · cites it directly13descendants
  • K050500Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2005 · 2 generations on12descendants
  • K051839Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc. · 2006 · 3 generations on10descendants
  • K092638Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22…Abbott Diabetes Care, Inc. · 2010 · 4 generations on4descendants
  • K070850Freestyle Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2007 · 4 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K945887Precision Q I D Blood Glucose Test StripsMedisense, Inc.1995—
−3K962295Precision Qid Blood Glucose Test StripMedisense, Inc.1996—
−2K963676Precision G Blood Glucose Testing SystemMedisense, Inc.1997—
−1K971812Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test StripMedisense, Inc.1997—
0 (this device)K982303Precision PCX Point of Care Management System , QC Manager Data Manager…Medisense, Inc.1998—
+1K022941Medisense Precision PCX Point of Care Management System for Blood Glucose…Abbott Laboratories2002—
+2K050500Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.2005—
+3K051839Free-Style Freedom Blood Glucose Monitoring System, Model 11001Abbott Diabetes Care, Inc.20062
+4K092638Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21…Abbott Diabetes Care, Inc.2010Class I
+4K070850Freestyle Lite Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc.20071

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199520
199610
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200520
200610
200710
200910
201022
201220
201320
201520
FIG. 1 — Lineage of K982303, 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.

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.

Top candidate predicates for a new CGA device

  1. #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 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? (6)

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
*K963676Precision G Blood Glucose Testing System
Summary page 1
…e Management System for Blood Glucose Testing Blood Glucose Testing System Glucose Test System Class II per 21 CFR 862.1345 Precision"G® Blood Glucose Testing System--K963676 Precision QID® Blood Glucose Testing System--K944195 Precision QID® and Precision-G® Blood Glucose Test Strip-- K945887, K962295,…
Medisense, Inc.1997—
*K944195Quickpro Blood Glucose Testing System
Summary page 1
…Glucose Testing System Glucose Test System Class II per 21 CFR 862.1345 Precision"G® Blood Glucose Testing System--K963676 Precision QID® Blood Glucose Testing System--K944195 Precision QID® and Precision-G® Blood Glucose Test Strip-- K945887, K962295, K971812 Johnson and Johnson Surestep Pro System --…
Medisense, Inc.1995—
*K945887Precision Q I D Blood Glucose Test Strips
Summary page 1
….1345 Precision"G® Blood Glucose Testing System--K963676 Precision QID® Blood Glucose Testing System--K944195 Precision QID® and Precision-G® Blood Glucose Test Strip-- K945887, K962295, K971812 Johnson and Johnson Surestep Pro System -- K970556 The Precision'G Plus Point of Care Management System for B…
Medisense, Inc.1995—
*K962295Precision Qid Blood Glucose Test Strip
Summary page 1
…ecision"G® Blood Glucose Testing System--K963676 Precision QID® Blood Glucose Testing System--K944195 Precision QID® and Precision-G® Blood Glucose Test Strip-- K945887, K962295, K971812 Johnson and Johnson Surestep Pro System -- K970556 The Precision'G Plus Point of Care Management System for Blood Gluc…
Medisense, Inc.1996—
*K971812Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip
Summary page 1
…® Blood Glucose Testing System--K963676 Precision QID® Blood Glucose Testing System--K944195 Precision QID® and Precision-G® Blood Glucose Test Strip-- K945887, K962295, K971812 Johnson and Johnson Surestep Pro System -- K970556 The Precision'G Plus Point of Care Management System for Blood Glucose Testi…
Medisense, Inc.1997—
*K970556Surestep Pro Blood Glucose Monitoring System
Summary page 1
…D® Blood Glucose Testing System--K944195 Precision QID® and Precision-G® Blood Glucose Test Strip-- K945887, K962295, K971812 Johnson and Johnson Surestep Pro System -- K970556 The Precision'G Plus Point of Care Management System for Blood Glucose Testing utilizes amperometric biosensor technology to gen…
Lifescan, Inc.19971

Also cleared against K963676: 2 other devices →

What descends from it? (14)

See all 14

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K022941Medisense Precision PCX Point of Care Management System for Blood Glucose TestingAbbott Laboratories200213

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 · 4 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 · 5 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls

What does this lineage say?

  • The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 1.3 years on median.
  • 1 of the 9 ancestors has a recall of any class.
  • Of its descendants, K022941 (Abbott Laboratories, 2002) has gone furthest, with 13 descendants of its own.
  • 2 other devices also cite its predicate K963676.

How does its category compare?

All CGA devices

CGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CGA

2in 2024

2007: 72008: 62009: 102010: 82011: 92012: 102013: 32014: 52015: 42016: 42017: 22018: 22019: 22020: 22021: 12022: 12023: 42024: 22026 (partial year): 1
2007high 10 (2009) · low 0 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CGA

249in 2023

2007: 122 days median2008: 56 days median2009: 155 days median2010: 122 days median2011: 217 days median2012: 123 days median2013: 441 days median2014: 265 days median2015: 150 days median2016: 157 days median2023: 249 days median
2007high 441 (2013) · low 56 (2008)2026

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

Recalls per year · CGA

3in 2023

2007: 22008: 22009: 42010: 62011: 32013: 32014: 22015: 6, 2 Class I2016: 22019: 12023: 3
2007high 6 (2010) · low 0 (2012)2026

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

Adverse event reports per year · CGA

59in 2025

2007: 292008: 372009: 752010: 1722011: 4232012: 2332013: 1722014: 1222015: 1552016: 362017: 922018: 692019: 1162020: 682021: 482022: 2722023: 1,1412024: 2662025: 59
2007high 1,141 (2023) · low 29 (2007)2025

MAUDE reports naming product code CGA, 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
20077122229
2008656237
200910155475
201081226172
201192173423
2012101230233
201334413172
201452652122
201541506 (2)155
20164157236
20172—092
20182—069
20192—1116
20202—068
20211—048
20221—0272
2023424931,141
20242—0266
20250—059
20261—0—

What is it indicated for?

The Precision G Plus 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 Precision'G Plus Point of Care Management System is for home (lay user)

or professional use.

The product may also be used by healthcare professionals for the quantitative

measurement of glucose in venous, arterial or neonatal whole blood, provided 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.

Also cleared against K963676

2 other devices cite the same predicate.

  • K983504Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra…Medisense, Inc. · 19991 recall
  • K971812Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test StripMedisense, Inc. · 1997

More from Medisense, Inc.

15 FDA decisions under this applicant name. See the company

  • K983504Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips, Precision Xtra…Medisense, Inc. · 19991 recall
  • K983253Precision A1C Home HBA1C Sample Collection KitMedisense, Inc. · 1998
  • K971812Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test StripMedisense, Inc. · 1997
  • K963676Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
  • K962295Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996

Recent decisions in CGA

The CGA category page

  • K252488ABL90 FLEX PLUS SystemRadiometer Medicals Aps · 2026
  • K210933YSI 2900C Biochemistry AnalyzerYsi, Inc. · 2024
  • K220328EasyStat 300Medica Corporation · 2024
  • K223179Cholestech LDX ™ SystemAlere San Diego, Inc. · 2023
  • K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023

https://510kreport.com/device/K982303 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982303: Precision PCX Point of Care Management System , QC Manager Data Manager System, Precision G Plus Blood Glucose Test ST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982303

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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