510(k) · Cleared
ClearedGL Goodlife Series Blood Glucose Monitoring Sysmtem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hmd Biomedical, Inc. · LFR Glucose Dehydrogenase, Glucose
Cleared on Jul 27, 2012 as substantially equivalent to K101509 (Taidoc Technology Corporation, 2011) and 1 other predicate after a 262-day review. Its family tree reaches back 4 generations to 2007. 1 later device descends from it.
- Decided
- Jul 27, 2012
- Review
- 262 days
- Class
- Class II
- Product code
- LFR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K070472 (2007). 6 ancestors in all, the oldest K023279 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK070472 Clever Chek TD-4230 Blood Glucose Monitoring System, RD-4230…Taidoc Technology Corporation · 2007
- 3 generations backK090187 Fora G30 Blood Glucose Monitoring System, Model TD-4241Taidoc Technology Corporation · 2009
- 2 generations backK094005 Fora G31A/TD-4256A Blood Glucose Monitoring System and Fora…Taidoc Technology Corporation · 2010
- 1 generation backK101509 U-Right TD-4279 Blood Glucose Monitoring System, Fora GD40/TD-4272…Taidoc Technology Corporation · 2011
- This deviceK113307 GL Goodlife Series Blood Glucose Monitoring SysmtemHmd Biomedical, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK140150 Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301…Hmd Biomedical, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K140150Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose…Hmd Biomedical, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K070472 | Clever Chek TD-4230 Blood Glucose Monitoring System, RD-4230, Surechek Blood… | Taidoc Technology Corporation | 2007 | — |
| −3 | K090187 | Fora G30 Blood Glucose Monitoring System, Model TD-4241 | Taidoc Technology Corporation | 2009 | — |
| −2 | K094005 | Fora G31A/TD-4256A Blood Glucose Monitoring System and Fora G31B/TD-4256B… | Taidoc Technology Corporation | 2010 | — |
| −1 | K101509 | U-Right TD-4279 Blood Glucose Monitoring System, Fora GD40/TD-4272 Blood… | Taidoc Technology Corporation | 2011 | — |
| 0 (this device) | K113307 | GL Goodlife Series Blood Glucose Monitoring Sysmtem | Hmd Biomedical, Inc. | 2012 | — |
| +1 | K140150 | Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose… | Hmd Biomedical, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 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? (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 |
|---|---|---|---|
| * | K101509 | U-Right TD-4279 Blood Glucose Monitoring System, Fora GD40/TD-4272 Blood Glucose…Summary page 2…Common name: Blood Glucose Test System Submitter: TaiDoc Technology Corporation 510(k) no.: K101509 Product code: NBW, LFR Common name: Glucose Control Solution Submitte… | 2011 |
| * | K032985 | Glucoleader Enhance Self-Monitoring of Blood Glucose SystemSummary page 2…LFR Common name: Glucose Control Solution Submitter: HMD Biomedical, Inc. 510(k) no.: K032985 Product code: JJX 4. Device Description GoodLife AC-300-'305 Blood Glucose Monitoring Syste… | 2003 |
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 |
|---|---|---|---|
| K140150 | Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose… | 2015 | 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 5 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K140150 (Hmd Biomedical, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K101509.
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 GoodLife AC-300 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-300 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. The GoodLife AC-300 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro…
Read the full statement (2,358 words)
The GoodLife AC-300 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-300 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
The GoodLife AC-300 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 to monitor the effectiveness of diabetes control. The GoodL-ife AC-300 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-300 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-300 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The GoodLife AC-301 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-301 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
The GoodLife AC-301 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 to monitor the effectiveness of diabetes control. The GoodLife AC-301 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-301 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-301 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The GoodLife AC-302 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-302 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
The GoodLife AC-302 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 to monitor the effectiveness of diabetes control. The GoodLife AC-302 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-302 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-302 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The GoodLife AC-303 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-303 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
The GoodLife AC-303 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 to monitor the effectiveness of diabetes control. The GoodLife AC-303 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-303 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-303 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The GoodLife AC-304 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-304 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
The GoodLife AC-304 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 to monitor the effectiveness of diabetes control. The GoodLife AC-304 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-304 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The GoodLife Glucose Control Solutions are for use with the Good Life AC-304 Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The GoodLife AC-305 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood sample drawn from the fingertips only. The GoodLife AC-305 Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.
The GoodLife AC-305 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 to monitor the effectiveness of diabetes control. The GoodLife AC-305 Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.
The GoodLife AC Blood Glucose Test Strips are for use with the GoodLife AC-30S Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-SOS Blood Glucose Meter and GoodLife AC Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The GoodLife AC-300 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-300 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.
The GoodLife AC-300 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The Good~ife AC-300 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.
The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-300 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The GoodLife Glucose Control Solutions are for use with the GoodL-ife AC-300 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The GoodLife AC-301 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-301 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.
The GoodLife AC-301 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-301 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.
The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-301 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-301 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and teststrips are working together properly and that the test is performing correctly.
The GoodLife AC-302 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-302 Professional Blood Glucose Monitoring System is intended to be Used for testing multiple patients by a health care professional in a clinical setting.
The GoodLife AC-302 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-302 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.
The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-302 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-302 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The GoodLife AC-303 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-303 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.
The GoodLife AC-303 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-303 Professional Blood Glucose Monitoring System should hot be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.
The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-303 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-303 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The GoodLife AC-304 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-304 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.
The GoodLife AC-304 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-304 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or fot neonatal use. This system should only be used with single-use, auto-disabling lancing devices.
The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-304 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-304 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.
The GoodLife AC-3O5 Professional Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips only. The GoodLife AC-3O5 Professional Blood Glucose Monitoring System is intended to be used for testing multiple patients by a health care professional in a clinical setting.
The GoodLife AC-305 Professional Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) by a health care professional in healthcare facilities as an aid to monitor the effectiveness of diabetes control. The GoodLife AC-3O5 Professional Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. This system should only be used with single-use, auto-disabling lancing devices.
The GoodLife AC Professional Blood Glucose Test Strip are for use with the GoodLife AC-305 Professional Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
The GoodLife Glucose Control Solutions are for use with the GoodLife AC-305 Professional Blood Glucose Meter and GoodLife AC Professional Blood Glucose 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/K113307 · printed Nov 3, 2026
Cite this page
510(k) Report. “K113307: GL Goodlife Series Blood Glucose Monitoring Sysmtem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113307
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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