510(k) · Cleared
ClearedLipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile and Glucose Measuring 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 Jun 21, 2013 as substantially equivalent to K090405 (Infopia Co, Ltd., 2009) after a 135-day review. Its family tree reaches back 4 generations to 1987.
- Decided
- Jun 21, 2013
- Review
- 135 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K870252 (1987). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK870252 Document (TM) Multi-Analyte Linearity Test SetCasco Standards · 1987
- 3 generations backK012117 Validate Chem 1 Calibration Verification Test Set, Model 10001Maine Standards Co. · 2001
- 2 generations backK022401 PTS Panels Multi-Chemistry ControlsPolymer Technology Systems, Inc. · 2002
- 1 generation backK090405 Lipidpro SystemInfopia Co, Ltd. · 2009
- This deviceK130295 Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro…Infopia Co, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K870252 | Document (TM) Multi-Analyte Linearity Test Set | Casco Standards | 1987 | — |
| −3 | K012117 | Validate Chem 1 Calibration Verification Test Set, Model 10001 | Maine Standards Co. | 2001 | — |
| −2 | K022401 | PTS Panels Multi-Chemistry Controls | Polymer Technology Systems, Inc. | 2002 | — |
| −1 | K090405 | Lipidpro System | Infopia Co, Ltd. | 2009 | — |
| 0 (this device) | K130295 | Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional… | Infopia Co, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2008 | 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 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 |
|---|---|---|---|
| * | K090405 | Lipidpro SystemSummary page 1…2.1705) Glucose test system (21 CFR Part 862.1345) . Quality control material (21 CFR Part 862.1660) * Product Code: CHH. LBR. JGY. NBW. CGA. JJX 4, Predicate Device: (K090405) LipidPro™ System, LipidPro™ Total Cholesterol Control Solution, LipidPro™ HDL Cholesterol Control Solution, LipidPro™ Triglyceri… | 2009 |
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 26 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- 3 of the 17 ancestors have a recall of any class.
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. 2013, 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 LipidPro® Lipid Profile and Glucose Measuring System is intended for self testing (in home) and for testing outside the body (in vitro diagnostic use only). The LipidPro® Lipid Profile and Glucose Measuring System, which consists of a meter and test strips, measures total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglyceride (TG) and glucose in capillary whole blood. The LipidPro® Lipid Profile and Glucose Measuring System is…
Read the full statement (904 words)
The LipidPro® Lipid Profile and Glucose Measuring System is intended for self testing (in home) and for testing outside the body (in vitro diagnostic use only). The LipidPro® Lipid Profile and Glucose Measuring System, which consists of a meter and test strips, measures total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglyceride (TG) and glucose in capillary whole blood. The LipidPro® Lipid Profile and Glucose Measuring System is intended to be used by a single patient and should not be shared.
The LipidPro® Total Cholesterol Test Strip, LipidPro® HDL-cholesterol Test Strip, LipidPro® Triglyceride Test Strip, LipidPro® Lipid Profile Test Strip, and LipidPro® Glucose Test Strip are for use with the LipidPro® Lipid Profile and Glucose Meter.
The LipidPro® Total Cholesterol Test Strip and the LipidPro® HDL-cholesterol Test Strip are used to measure total cholesterol (TC) and high density lipoprotein cholesterol (HDL-C) in capillary whole blood respectively and the measurements obtained are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid, and lipoprotein metabolism disorders. The LipidPro® Total Cholesterol Test Strip and LipidPro® HDL-cholesterol Test Strip measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. The LipidPro® Triglyceride Test Strip is used to measure triglyceride (TG) in capillary whole blood and the obtained measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism, or various endocrine disorders. Calculated LDL-cholesterol values are reported only when triglycerides are < 350 mg/dL; when triglycerides are > 350 mg/dL, calculated LDL-cholesterol are not reported.
The LipidPro® Lipid Profile Test Strip is used to measure TC, HDL-C, and TG in capillary whole blood at the same time.
The LipidPro® Glucose Test Strip is for the quantitative measurement of the concentration of glucose in capillary whole blood that can be taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh by diabetic patients as an aid in the management of diabetes. Glucose measurement is not to be used for the diagnosis of or screening for diabetes and/or for neonatal use. Alternate site testing should be done during steady-state times when glucose is not changing rapidly.
LipidPro® Total Cholesterol Control Solution, HDL-cholesterol Control Solution, Triglycerides Control Solution, and Glucose Control Solution are used to test the precision of the LipidPro® Lipid Profile and Glucose Measuring System and to detect systematic analytic deviations that may arise from reagent or analytical variation and they are for testing outside the body (in vitro diagnostic use only). LipidPro® Control Solutions are intended for use in home.
The LipidPro® Professional Lipid Profile and Glucose Measuring System is intended for multiple patient use in professional health care settings and for testing outside the body (in vitro diagnostic use only). The LipidPro® Professional Lipid Profile and Glucose Measuring System which consists of meter and test strips, measures total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), triglyceride (TG), and glucose in capillary whole blood. The LipidPro® Professional Lipid Profile and Glucose Measuring System should only be used with auto-disabling, single-use lancing device.
The LipidPro® Professional Total Cholesterol Test Strip, LipidPro® Professional HDL-cholesterol Test Strip, LipidPro® Professional Triglyceride Test Strip, LipidPro® Professional Lipid Profile Test Strip, and LipidPro® Professional Glucose Test Strip are for use with the LipidPro® Professional Lipid Profile and Glucose Meter.
The LipidPro® Professional Total Cholesterol Test strip and the LipidPro® Professional HDL-cholesterol Test Strip are used to measure total cholesterol (TC) and high density lipoprotein cholesterol (HDL-C) in capillary whole blood respectively and the measurements obtained are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid, and lipoprotein metabolism disorders. The LipidPro® Professional Total Cholesterol Test strip and LipidPro® Professional HDL-cholesterol Test Strip measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. The LipidPro® Professional Triglyceride Test Strip is used to measure triglyceride (TG) in capillary whole blood and the obtained measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, and other diseases involving lipid metabolism, or various endocrine disorders. Calculated LDL-cholesterol values are reported only when triglycerides are < 350 mg/dL; when triglycerides are > 350 mg/dL, calculated LDL-cholesterol are not reported.
The LipidPro® Professional Lipid Profile Test Strip is used to measure TC, HDL-C, and TG in capillary whole blood at the same time.
The LipidPro® Professional Glucose Test Strip is for the quantitative measurement of the concentration of glucose in capillary whole blood that can be taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh by diabetic patients as an aid in the management of diabetes. Glucose measurement is not to be used for the diagnosis of or screening for diabetes and/or for neonatal use. Alternate site testing should be done during steady-state times when glucose is not changing rapidly.
The LipidPro® Professional Total Cholesterol Control Solution, HDL-cholesterol Control Solution, Triglycerides Control Solution, and Glucose Control Solution are used to test the precision of the LipidPro® Professional Lipid Profile and Glucose Measuring System and to detect systematic analytic deviations that may arise from reagent or analytical variation and they are for testing outside the body (in vitro diagnostic use only). The LipidPro® Professional Control Solutions are intended for use in hospital and professional health care settings.
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/K130295 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130295: Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile and Glucose Measuring System..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130295
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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