510(k) · Cleared
ClearedElement Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infopia Co, Ltd. · CGA Glucose Oxidase, Glucose
Cleared on May 8, 2012 as substantially equivalent to K103021 (Infopia Co, Ltd., 2011) after a 147-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- May 8, 2012
- Review
- 147 days
- Class
- Class II
- Product code
- CGA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K950727 (1995). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK950727 One Touch Profile Complete Diabetes Tracking SystemLifescan, Inc. · 1995
- 3 generations backK021819 One Touch Ultrasmart Blood Glucose Monitoring SystemLifescan, Inc. · 2002 · Recalled
- 2 generations backK072369 Evolution Blood Glucose Monitoring SystemHmd Biomedical, LLC · 2008
- 1 generation backK103021 Element Plus Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2011
- This deviceK113670 Element Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK133045 Element TM Lite Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2014
Most influential descendants
Showing 1 of 1 · See all- K133045Element TM Lite Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K950727 | One Touch Profile Complete Diabetes Tracking System | Lifescan, Inc. | 1995 | — |
| −3 | K021819 | One Touch Ultrasmart Blood Glucose Monitoring System | Lifescan, Inc. | 2002 | 1 |
| −2 | K072369 | Evolution Blood Glucose Monitoring System | Hmd Biomedical, LLC | 2008 | — |
| −1 | K103021 | Element Plus Blood Glucose Monitoring System | Infopia Co, Ltd. | 2011 | — |
| 0 (this device) | K113670 | Element Blood Glucose Monitoring System | Infopia Co, Ltd. | 2012 | — |
| +1 | K133045 | Element TM Lite Blood Glucose Monitoring System | Infopia Co, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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.
Planning a device in CGA? 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? (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 |
|---|---|---|---|
| * | K103021 | Element Plus Blood Glucose Monitoring SystemSummary page 3…Blood Glucose Monitoring System is as safe, as effective and performs as well as the legally marketed predicate device, Element TM plus Blood Glucose Test System (K 103021). 5 10O(k) Submission 5 10(k) summary , 3 /3 page DEPART… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133045 | Element TM Lite Blood Glucose Monitoring System | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K133045 (Infopia Co, Ltd., 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K103021.
How does its category compare?
All CGA devicesCGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 Element T' Blood Glucose Monitoring System is fot the quantitative measurement of glucose in capillary whole blood taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh. Element Blood Glucose Testing System is for in vitro diagnostic use and is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Element TmBlood Glucose Monitoring System is intended to be used by a single patient and…
Read the full statement (211 words)
The Element T' Blood Glucose Monitoring System is fot the quantitative measurement of
glucose in capillary whole blood taken from the fingertip, ventral palm, dorsal hand, upper arm,
forearm, calf and/or thigh. Element Blood Glucose Testing System is for in vitro diagnostic
use and is not to be used for the diagnosis of or screening for diabetes or for neonatal use.
Element TmBlood Glucose Monitoring System is intended to be used by a single patient and
should not be shared.
The Element 'T' Blood Glucose Monitoring System is intended for self testing outside the body
(in vitro diagnostic use) by people with diabetes at home as an aid in the management of diabetes.
Alternative site Testing (ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh) should
be done during steady- state times when glucose is not changing rapidly.
The Element Tm Test Strips are for use with the ElemenJ"' Blood Glucose Meter to quantitatively
measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip, ventral
palm, dorsal hand, upper arm, forearm, calf and/or thigh.
The ElmntT control solutions are for use with the Element TMBlood Glucose Monitoring
system to check that the meter and the test strips are working together properly and the test is
performing correctly.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113670 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113670: Element Blood Glucose Monitoring System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113670
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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