510(k) · Cleared
ClearedGoodlife CS-200 (Single Patient Use), CS-200 Professional (Multiple Patient Use) Blood Glucose Monitoring Systems
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 Feb 14, 2013 as substantially equivalent to K101509 (Taidoc Technology Corporation, 2011) after a 276-day review. Its family tree reaches back 4 generations to 2007.
- Decided
- Feb 14, 2013
- Review
- 276 days
- Class
- Class II
- Product code
- LFR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K070472 (2007). No later device cites it as a predicate yet.
- 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 deviceK121433 Goodlife CS-200 (Single Patient Use), CS-200 Professional (Multiple…Hmd Biomedical, Inc. · 2013
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) | K121433 | Goodlife CS-200 (Single Patient Use), CS-200 Professional (Multiple Patient… | Hmd Biomedical, Inc. | 2013 | — |
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 |
|---|---|---|---|
| * | K101509 | U-Right TD-4279 Blood Glucose Monitoring System, Fora GD40/TD-4272 Blood Glucose…Summary page 1…System Clinical Chemistry (75) 862.1345 (Class II) NBW, LFR U-RIGHT TD-4279A Blood Glucose Monitoring System Blood Glucose Test System TaiDoc Technology Corporation K101509 NBW, LFR 6-1 HMD BioMedical Inc. GoodLife CS-200 Blood Glucose Monitoring System and GoodLife CS-200 Professio… | 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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- None of the 4 ancestors has a recall.
- 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. 2013, 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 CS-200 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 CS-200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The GoodLife CS-200 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with…
Read the full statement (283 words)
The GoodLife CS-200 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 CS-200 Blood Glucose
Monitoring System is intended to be used by a single person and should not be
shared.
The GoodLife CS-200 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 CS-200
Blood Glucose Monitoring System should not be used for the diagnosis of or
screening of diabetes or for neonatal use.
The GoodLife KP Blood Glucose Test Strips are for use with the GoodLife
CS-200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh
capillary whole blood samples drawn from the fingertips only.
The GoodLife CS-200 Professional Blood Glucose Monitoring System is intended
to be used for the quantitative measurement of glucose (sugar) in venous or
arterial whole blood or fresh capillary whole blood drawn from the fingertips. It is
intended for testing outside the body (in vitro diagnostic use) and is intended for
multiple-patient use in professional healthcare settings as an aid to monitor the
effectiveness of a diabetes control program. This system should only be used with
single-use, auto-disabling lancing devices.
The GoodLife CS-200 Professional Blood Glucose Monitoring System should not
be used for the diagnosis of or screening of diabetes or for neonatal use.
The GoodLife KP Professional Blood Glucose Test Strip is for use with the
GoodLife CS-200 Professional Blood Glucose Meter to quantitatively measure
glucose (sugar) in venous or arterial whole blood or fresh capillary drawn from the
fingertips.
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/K121433 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121433: Goodlife CS-200 (Single Patient Use), CS-200 Professional (Multiple Patient Use) Blood Glucose Monitoring Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121433
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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