510(k) · Cleared
ClearedPrecision G Blood Glucose Testing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medisense, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Feb 20, 1997 as substantially equivalent to K944195 (Medisense, Inc., 1995) and 3 other predicates after a 160-day review. Its family tree reaches back 2 generations to 1995. 3 of the 66 devices in its family, counting itself, have a Class I recall. 60 later devices descend from it.
- Decided
- Feb 20, 1997
- Review
- 160 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K945887 (1995). 5 ancestors in all, the oldest K896951 (1990). 60 later devices descend from it, 3 citing it directly. 3 of the 66 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- 1 generation backK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- This deviceK963676 Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997
- Descendant · cites it directly · 59 of its ownK971812 Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose…Medisense, Inc. · 1997
- Descendant · cites it directly · 40 of its ownK983504 Precision Xtra Advanced Diabetes Management System, Precision Blood…Medisense, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 19 of its ownK052980 Liberty Glucose Control, Model 2120031Liberty Healthcare Group, Inc. · 2005
- Descendant · 2 generations on · 16 of its ownK040814 Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories · 2004 · Recalled
- Descendant · cites it directly · 14 of its ownK982303 Precision PCX Point of Care Management System , QC Manager Data…Medisense, Inc. · 1998
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 60 · See all- K971812Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test StripMedisense, Inc. · 1997 · cites it directly59descendants
- K983504Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips…Medisense, Inc. · 1999 · cites it directly40descendants
- K052980Liberty Glucose Control, Model 2120031Liberty Healthcare Group, Inc. · 2005 · 2 generations on19descendants
- K040814Modification to Precision Xtra Advanced Diabetes Management SystemAbbott Laboratories · 2004 · 2 generations on16descendants
- K982303Precision PCX Point of Care Management System , QC Manager Data Manager System…Medisense, Inc. · 1998 · cites it directly14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| −1 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| 0 (this device) | K963676 | Precision G Blood Glucose Testing System | Medisense, Inc. | 1997 | — |
| +1 | K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | Medisense, Inc. | 1997 | — |
| +1 | K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose… | Medisense, Inc. | 1999 | 1 |
| +2 | K052980 | Liberty Glucose Control, Model 2120031 | Liberty Healthcare Group, Inc. | 2005 | — |
| +2 | K040814 | Modification to Precision Xtra Advanced Diabetes Management System | Abbott Laboratories | 2004 | 3 |
| +1 | K982303 | Precision PCX Point of Care Management System , QC Manager Data Manager… | Medisense, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 6 | 0 |
| 2007 | 5 | 0 |
| 2008 | 7 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 3 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 6 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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.
3 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 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K944195 | Quickpro Blood Glucose Testing SystemSummary page 1…Precision G Blood Glucose Testing System Blood Glucose Testing System “Glucose Test System” - Class II per CFR 862.1345 Precision QID Blood Glucose Testing System - K944195 Precision QID Blood Glucose Test Strip - K945887, K962295 Satellite G Blood Glucose Testing System - K896951 The Precision G Blo… | 1995 |
| * | K945887 | Precision Q I D Blood Glucose Test StripsSummary page 1…Glucose Testing System “Glucose Test System” - Class II per CFR 862.1345 Precision QID Blood Glucose Testing System - K944195 Precision QID Blood Glucose Test Strip - K945887, K962295 Satellite G Blood Glucose Testing System - K896951 The Precision G Blood Glucose Testing System utilizes amperometric b… | 1995 |
| * | K962295 | Precision Qid Blood Glucose Test StripSummary page 1…Testing System “Glucose Test System” - Class II per CFR 862.1345 Precision QID Blood Glucose Testing System - K944195 Precision QID Blood Glucose Test Strip - K945887, K962295 Satellite G Blood Glucose Testing System - K896951 The Precision G Blood Glucose Testing System utilizes amperometric biosensor… | 1996 |
| * | K896951 | Satellite G Blood Glucose Monitoring SystemSummary page 1…r CFR 862.1345 Precision QID Blood Glucose Testing System - K944195 Precision QID Blood Glucose Test Strip - K945887, K962295 Satellite G Blood Glucose Testing System - K896951 The Precision G Blood Glucose Testing System utilizes amperometric biosensor technology to quantitatively measure glucose in who… | 1990 |
What descends from it? (60)
See all 603 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971812 | Precision Qid Blood Glucose Test Strip, Precision G Blood Glucose Test Strip | 1997 | 59 |
| K983504 | Precision Xtra Advanced Diabetes Management System, Precision Blood Glucose Test Strips… | 1999 | 40 |
| K982303 | Precision PCX Point of Care Management System , QC Manager Data Manager System… | 1998 | 14 |
Has anything in its family been recalled? (3 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.
- K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max…Nova Biomedical Corp. · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 110 Class I recalls
- K092638Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22, 12101-23Abbott Diabetes Care, Inc. · 2010 · 5 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 · 6 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 1.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K971812 (Medisense, Inc., 1997) has gone furthest, with 59 descendants of its own.
- 2 other devices also cite its predicate K944195.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CGA
249in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CGA
3in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CGA
59in 2025
MAUDE reports naming product code CGA, 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 | 7 | 122 | 2 | 29 |
| 2008 | 6 | 56 | 2 | 37 |
| 2009 | 10 | 155 | 4 | 75 |
| 2010 | 8 | 122 | 6 | 172 |
| 2011 | 9 | 217 | 3 | 423 |
| 2012 | 10 | 123 | 0 | 233 |
| 2013 | 3 | 441 | 3 | 172 |
| 2014 | 5 | 265 | 2 | 122 |
| 2015 | 4 | 150 | 6 (2) | 155 |
| 2016 | 4 | 157 | 2 | 36 |
| 2017 | 2 | — | 0 | 92 |
| 2018 | 2 | — | 0 | 69 |
| 2019 | 2 | — | 1 | 116 |
| 2020 | 2 | — | 0 | 68 |
| 2021 | 1 | — | 0 | 48 |
| 2022 | 1 | — | 0 | 272 |
| 2023 | 4 | 249 | 3 | 1,141 |
| 2024 | 2 | — | 0 | 266 |
| 2025 | 0 | — | 0 | 59 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Precision G Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh whole blood. The Precision G Blood Glucose Testing System is intended for home or professional use. The product may also be used by healthcare professionals for quantitative measurement of glucose in venous or arterial whole blood, provided the sample is used within 15 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/K963676 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963676: Precision G Blood Glucose Testing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963676
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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