510(k) · Cleared
ClearedElect II Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Selfcare, Inc. · CGA Glucose Oxidase, Glucose
Cleared on Jun 20, 1997 as substantially equivalent to K961985 (Selfcare, Inc., 1996) and 1 other predicate after a 114-day review. Its family tree reaches back 1 generation to 1995. 3 of the 39 devices in its family, counting itself, have a Class I recall. 36 later devices descend from it.
- Decided
- Jun 20, 1997
- Review
- 114 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K945887 (1995). 2 ancestors in all. 36 later devices descend from it, 2 citing it directly. 3 of the 39 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK945887 Precision Q I D Blood Glucose Test StripsMedisense, Inc. · 1995
- This deviceK970707 Elect II Blood Glucose Monitoring SystemSelfcare, Inc. · 1997
- Descendant · cites it directly · 33 of its ownK992684 Freestyle Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2000 · Recalled
- Descendant · 2 generations on · 23 of its ownK012014 Modification to Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2001
- Descendant · 2 generations on · 22 of its ownK020866 Freestyle Tracker Diabetes Management SystemAbbott Diabetes Care, Inc. · 2002
- Descendant · 2 generations on · 18 of its ownK031260 Freestyle Blood Glucose Monitoring System, Freestyle Tracker…Abbott Diabetes Care, Inc. · 2003
- Descendant · 2 generations on · 12 of its ownK050500 Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2005
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 36 · See all- K992684Freestyle Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2000 · cites it directly33descendants
- K012014Modification to Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2001 · 2 generations on23descendants
- K020866Freestyle Tracker Diabetes Management SystemAbbott Diabetes Care, Inc. · 2002 · 2 generations on22descendants
- K031260Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes Management System…Abbott Diabetes Care, Inc. · 2003 · 2 generations on18descendants
- K050500Freestyle 600 Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2005 · 2 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945887 | Precision Q I D Blood Glucose Test Strips | Medisense, Inc. | 1995 | — |
| 0 (this device) | K970707 | Elect II Blood Glucose Monitoring System | Selfcare, Inc. | 1997 | — |
| +1 | K992684 | Freestyle Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2000 | 2 |
| +2 | K012014 | Modification to Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2001 | — |
| +2 | K020866 | Freestyle Tracker Diabetes Management System | Abbott Diabetes Care, Inc. | 2002 | — |
| +2 | K031260 | Freestyle Blood Glucose Monitoring System, Freestyle Tracker Diabetes… | Abbott Diabetes Care, Inc. | 2003 | — |
| +2 | K050500 | Freestyle 600 Blood Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 2 |
| 2011 | 1 | 0 |
| 2012 | 4 | 1 |
| 2013 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K961985 | Elect Blood Glucose Monitorig SystemSummary page 1…control) Class | as per 21 CFR Section 878.4800, Code 79 FMK (lancet, blood) None established under section 514 Elect Blood Glucose Monitoring System (Selfcare, Inc. K961985) Precision Q.1.D. Blood Glucose Monitoring System (Medisense, Inc. K945887) 80 Product Description: The Elect… | 1996 |
| * | K945887 | Precision Q I D Blood Glucose Test StripsSummary page 1…d) None established under section 514 Elect Blood Glucose Monitoring System (Selfcare, Inc. K961985) Precision Q.1.D. Blood Glucose Monitoring System (Medisense, Inc. K945887) 80 Product Description: The Elect |l Blood Glucose Monitoring System comprises a glucose reagent test strip, a… | 1995 |
What descends from it? (36)
See all 362 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- K092638Freestyle Blood Glucose Test Strips, Models 100-Count: 12401-01, 12101-21, 12101-22, 12101-23Abbott Diabetes Care, Inc. · 2010 · 2 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
- K120568Freestyle Insulinx Blood Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K992684 (Abbott Diabetes Care, Inc., 2000) has gone furthest, with 33 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 | — |
What is it indicated for?
The Elect II Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The Elect II System is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor the effectiveness of diabetes control.
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/K970707 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970707: Elect II Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970707
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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