510(k) · Cleared
ClearedGenesis Health Technologies Blood Glucose Monitoring System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taidoc Technology Corporation · LFR Glucose Dehydrogenase, Glucose
Cleared on Sep 19, 2012 as substantially equivalent to K101631 (Taidoc Technology Corporation, 2011) after a 152-day review. Its family tree reaches back 1 generation to 2011.
- Decided
- Sep 19, 2012
- Review
- 152 days
- Class
- Class II
- Product code
- LFR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K101631 (2011). No later device cites it as a predicate yet.
- Root · 1 generation backK101631 Fora GD20 Blood Glucose Monitoring System, U-Rught TD-4252D Blood…Taidoc Technology Corporation · 2011
- This deviceK121224 Genesis Health Technologies Blood Glucose Monitoring SystemTaidoc Technology Corporation · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K101631 | Fora GD20 Blood Glucose Monitoring System, U-Rught TD-4252D Blood Glucose… | Taidoc Technology Corporation | 2011 | — |
| 0 (this device) | K121224 | Genesis Health Technologies Blood Glucose Monitoring System | Taidoc Technology Corporation | 2012 | — |
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 LFR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K101631 | Fora GD20 Blood Glucose Monitoring System, U-Rught TD-4252D Blood Glucose Monitoring…Summary page 2…bstantial Equivalence Information: A. Predicate device name: U-RIGHT TD-4252 Blood Glucose Monitoring System, model TD-4252 B. Predicate K number: K101631 C. Comparison with predicate: The modified Genesis Health Technologies Blood Glucose Monitoring System has the… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K101631.
How does its category compare?
All LFR devicesLFR Glucose Dehydrogenase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LFR
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · LFR
161in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFR
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFR
827in 2025
MAUDE reports naming product code LFR, 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 | 1 | — | 3 | 23,819 |
| 2008 | 0 | — | 1 | 6,584 |
| 2009 | 1 | — | 4 | 10,823 |
| 2010 | 0 | — | 0 | 4,865 |
| 2011 | 6 | 296 | 1 | 3,802 |
| 2012 | 13 | 152 | 1 | 3,341 |
| 2013 | 3 | 212 | 0 | 3,821 |
| 2014 | 3 | 161 | 0 | 3,960 |
| 2015 | 1 | — | 0 | 3,366 |
| 2016 | 0 | — | 0 | 2,145 |
| 2017 | 0 | — | 0 | 103 |
| 2018 | 0 | — | 0 | 108 |
| 2019 | 0 | — | 0 | 108 |
| 2020 | 0 | — | 0 | 132 |
| 2021 | 0 | — | 0 | 164 |
| 2022 | 0 | — | 0 | 101 |
| 2023 | 0 | — | 0 | 103 |
| 2024 | 0 | — | 0 | 171 |
| 2025 | 0 | — | 0 | 827 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Genesis Health Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger and the following alternative sites: the palm, the forearm, and the upper-arm. It is intended for use by people wit diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is…
Read the full statement (190 words)
The Genesis Health Blood Glucose Monitoring System is intended for use in the
quantitative measurement of glucose in fresh capillary whole blood from the finger and
the following alternative sites: the palm, the forearm, and the upper-arm. It is intended for
use by people wit diabetes mellitus at home as an aid in monitoring the effectiveness of
diabetes control program. It is not intended for the diagnosis of or screening for diabetes
mellitus, and is not intended for use on neonates.
This system is intended to be used by a single person and should not be shared.
The Genesis Health Technologies test strips are for use with the Genesis Health
Technologies meter to quantitatively measure glucose (sugar) in fresh capillary whole
blood samples drawn from fingertips, palm, forearm and upper arm.
The alternative site testing in the Genesis Health Blood Glucose Monitoring System can
be used only during steady-state blood glucose conditions.
The Genesis Health Technologies control solutions are for use with the Genesis Health
Blood Glucose meter and test strips to check that the meter and test strips are working
together properly and that the test is performing correctly.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121224 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121224: Genesis Health Technologies 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/K121224
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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