510(k) · Cleared
ClearedElement Plus Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infopia Co, Ltd. · NBW System, Test, Blood Glucose, Over The Counter
Cleared on Nov 4, 2011 as substantially equivalent to K072369 (Hmd Biomedical, LLC, 2008) after a 388-day review. Its family tree reaches back 3 generations to 1995. 3 later devices descend from it.
- Decided
- Nov 4, 2011
- Review
- 388 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K950727 (1995). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK950727 One Touch Profile Complete Diabetes Tracking SystemLifescan, Inc. · 1995
- 2 generations backK021819 One Touch Ultrasmart Blood Glucose Monitoring SystemLifescan, Inc. · 2002 · Recalled
- 1 generation backK072369 Evolution Blood Glucose Monitoring SystemHmd Biomedical, LLC · 2008
- This deviceK103021 Element Plus Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK113670 Element Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK132406 Elementv Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK133045 Element TM Lite Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2014
Most influential descendants
Showing 3 of 3 · See all- K113670Element Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2012 · cites it directly1descendant
- K132406Elementv Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2014 · cites it directly0descendants
- K133045Element TM Lite Blood Glucose Monitoring SystemInfopia Co, Ltd. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950727 | One Touch Profile Complete Diabetes Tracking System | Lifescan, Inc. | 1995 | — |
| −2 | K021819 | One Touch Ultrasmart Blood Glucose Monitoring System | Lifescan, Inc. | 2002 | 1 |
| −1 | K072369 | Evolution Blood Glucose Monitoring System | Hmd Biomedical, LLC | 2008 | — |
| 0 (this device) | K103021 | Element Plus Blood Glucose Monitoring System | Infopia Co, Ltd. | 2011 | — |
| +1 | K113670 | Element Blood Glucose Monitoring System | Infopia Co, Ltd. | 2012 | — |
| +1 | K132406 | Elementv Blood Glucose Monitoring System | Infopia Co, Ltd. | 2014 | — |
| +2 | 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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 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.
Planning a device in NBW? 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 NBW device
- #1 K260545 CONTOUR® PLUS BLUE Blood Glucose Monitoring…score 14.6 · 10 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 |
|---|---|---|---|
| * | K072369 | Evolution Blood Glucose Monitoring SystemSummary page 1…ised of test meter, test strip and control solutions. Element mplus blood glucose test meter is substantially identical with the predicate device (EvolutionT m : K072369). The minor difference is that Element"'m plus test meter has voice function, which Eouinmtest meter does not have. The voice… | 2008 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K113670 (Infopia Co, Ltd., 2012) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K072369.
How does its category compare?
All NBW devicesNBW System, Test, Blood Glucose, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NBW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NBW
243in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NBW
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NBW
4,745in 2025
MAUDE reports naming product code NBW, 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 | 29 | 85 | 9 | 7,991 |
| 2008 | 37 | 128 | 2 | 7,704 |
| 2009 | 38 | 140 | 5 | 10,963 |
| 2010 | 31 | 132 | 11 | 11,631 |
| 2011 | 30 | 328 | 1 | 22,909 |
| 2012 | 30 | 230 | 1 | 23,449 |
| 2013 | 47 | 167 | 5 (2) | 35,408 |
| 2014 | 24 | 202 | 1 | 38,524 |
| 2015 | 32 | 237 | 0 | 62,111 |
| 2016 | 20 | 233 | 1 | 76,621 |
| 2017 | 25 | 244 | 0 | 37,538 |
| 2018 | 19 | 168 | 0 | 16,911 |
| 2019 | 10 | 127 | 14 | 14,472 |
| 2020 | 7 | 121 | 0 | 10,703 |
| 2021 | 7 | 465 | 0 | 9,198 |
| 2022 | 12 | 410 | 0 | 8,103 |
| 2023 | 5 | 193 | 0 | 7,256 |
| 2024 | 7 | 243 | 0 | 6,220 |
| 2025 | 2 | — | 1 | 4,745 |
| 2026 | 5 | 190 | 0 | — |
What is it indicated for?
The Element TM plus Blood Glucose Monitoring System is for 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 "mplus 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 T plus Blood Glucose Monitoring System is intended to be used by a…
Read the full statement (203 words)
The Element TM plus Blood Glucose Monitoring System is for 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 "mplus 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 T
plus Blood Glucose Monitoring System is intended to be used by a single patient and should not be
shared.
The Element TM plus Blood Glucose Monitoring System is intended for self testing outside the hody
(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 Elemen t TM plus Test Strips are for use with the ElementM plus 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.
This meter contains some speaking functions but has not been validated for use by the visually
impaired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103021: Element Plus 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/K103021
Report an extraction error
Are you the manufacturer?
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