510(k) · Cleared
ClearedPrecision Q I D Blood Glucose Test Strips
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 Mar 23, 1995 after a 112-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 of the 78 devices in its family, counting itself, have a Class I recall. 77 later devices descend from it.
- Decided
- Mar 23, 1995
- Review
- 112 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 0
77 later devices descend from it, 6 citing it directly. 4 of the 78 devices in this family, counting this one, have a Class I recall.
- This deviceK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- Descendant · cites it directly · 61 of its ownK962295 Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996
- Descendant · cites it directly · 60 of its ownK963676 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 · cites it directly · 36 of its ownK970707 Elect II Blood Glucose Monitoring SystemSelfcare, Inc. · 1997
Showing 5 of 77 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K091547 Nova Max Plus Blood Glucose and B-Ketone Monitor…3 generations on · 2010
- K092638 Freestyle Blood Glucose Test Strips, Models…3 generations on · 2010
- K092602 FREESTYLE Lite Blood Glucose Monitoring System…5 generations on · 2010
- K120568 Freestyle Insulinx Blood Glucose Monitoring System5 generations on · 2012
Most influential descendants
Showing 5 of 77 · See all- K962295Precision Qid Blood Glucose Test StripMedisense, Inc. · 1996 · cites it directly61descendants
- K963676Precision G Blood Glucose Testing SystemMedisense, Inc. · 1997 · cites it directly60descendants
- 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
- K970707Elect II Blood Glucose Monitoring SystemSelfcare, Inc. · 1997 · cites it directly36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| +1 | K962295 | Precision Qid Blood Glucose Test Strip | Medisense, Inc. | 1996 | — |
| +1 | 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 |
| +1 | K970707 | Elect II Blood Glucose Monitoring System | Selfcare, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 6 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 6 | 0 |
| 2007 | 6 | 0 |
| 2008 | 7 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 3 |
| 2011 | 1 | 0 |
| 2012 | 4 | 1 |
| 2013 | 6 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
4 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (77)
See all 776 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962295 | Precision Qid Blood Glucose Test Strip | 1996 | 61 |
| K963676 | Precision G Blood Glucose Testing System | 1997 | 60 |
| 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 |
| K970707 | Elect II Blood Glucose Monitoring System | 1997 | 36 |
| K982303 | Precision PCX Point of Care Management System , QC Manager Data Manager System… | 1998 | 14 |
Has anything in its family been recalled? (4 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 · 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 · 5 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
- K120568Freestyle Insulinx Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K962295 (Medisense, Inc., 1996) has gone furthest, with 61 descendants of its own.
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 | — |
https://510kreport.com/device/K945887 · printed Nov 6, 2026
Cite this page
510(k) Report. “K945887: Precision Q I D Blood Glucose Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945887
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026