510(k) · Cleared
ClearedLipidpro 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 Dec 1, 2009 as substantially equivalent to K023558 (Polymer Technology Systems, Inc., 2002) and 2 other predicates after a 285-day review. Its family tree reaches back 3 generations to 1987. 1 later device descends from it.
- Decided
- Dec 1, 2009
- Review
- 285 days
- Class
- Class II
- Product code
- NBW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K870252 (1987). 16 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK870252 Document (TM) Multi-Analyte Linearity Test SetCasco Standards · 1987
- 2 generations backK012117 Validate Chem 1 Calibration Verification Test Set, Model 10001Maine Standards Co. · 2001
- 1 generation backK022401 PTS Panels Multi-Chemistry ControlsPolymer Technology Systems, Inc. · 2002
- This deviceK090405 Lipidpro SystemInfopia Co, Ltd. · 2009
- Descendant · cites it directly · 0 of its ownK130295 Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro…Infopia Co, Ltd. · 2013
Most influential descendants
Showing 1 of 1 · See all- K130295Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile…Infopia Co, Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K870252 | Document (TM) Multi-Analyte Linearity Test Set | Casco Standards | 1987 | — |
| −2 | K012117 | Validate Chem 1 Calibration Verification Test Set, Model 10001 | Maine Standards Co. | 2001 | — |
| −1 | K022401 | PTS Panels Multi-Chemistry Controls | Polymer Technology Systems, Inc. | 2002 | — |
| 0 (this device) | K090405 | Lipidpro System | Infopia Co, Ltd. | 2009 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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? (3)
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 |
|---|---|---|---|
| * | K023558 | PTS Panels Lipid Panel Test StripsSummary page 1…aterial (assayed and unassayed) (21 CFR Part 862.1660, JJX) 6. Predicate - Predicate for the Lipid profile test system PTS PANELS Lipid Panel Test Strips (K023558) / Polymer Technology Systems, Inc. - Predicate for the glucose test system Evolution~m Blood Glucose Test System… | 2002 |
| * | K072369 | Evolution Blood Glucose Monitoring SystemSummary page 1…ANELS Lipid Panel Test Strips (K023558) / Polymer Technology Systems, Inc. - Predicate for the glucose test system Evolution~m Blood Glucose Test System (K072369) / HMD Biomedical LLC. LipiPro"m 510(K) Submission… | 2008 |
| * | K022401 | PTS Panels Multi-Chemistry ControlsSummary page 4…gally marketed predicate device, PTS PANELS Lipid Panel Test Strips (K023558), Evolutionrh Blood Glucose Test System (K(072369) and PTS Panels Multi-Chemristry Controls (K022401). Similarities and Differences of the Lipid profile measuring system ~~Item… | 2002 |
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 |
|---|---|---|---|
| K130295 | Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile… | 2013 | 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 22 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- 3 of the 16 ancestors have a recall of any class.
- Of its descendants, K130295 (Infopia Co, Ltd., 2013) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K023558.
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. 2009, 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?
LipidProtm system is intended for in home (self-testing) or health care professionals and for testing outside the body (in vitro diagnostic use only). LipidPro Tm 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. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in…
Read the full statement (295 words)
LipidProtm system is intended for in home (self-testing) or health care professionals and for testing outside the body (in vitro diagnostic use only). LipidPro Tm 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.
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various liver and renal diseases. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, 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.
Glucose measurement 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 or health care professionals as an aid in the management of diabetes. Glucose measurement is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Alternate site testing should be done during steady- state times when glucose is not changing rapidly.
LipidProTm Total Cholesterol control solution, HDL-cholesterol control solution, Triglyceride control solution, and Glucose control solution are used to test the precision of the LipidPro TM 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 TM control solutions are intended for in home and health care professionals use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090405 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090405: Lipidpro System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090405
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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