510(k) · Cleared
Recalled · 2009MTM Bioscanner C Test Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymer Technology Systems, Inc. · CHH Enzymatic Esterase--Oxidase, Cholesterol
Cleared on Jun 24, 1999 after a 119-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it. It has been recalled once.
- Decided
- Jun 24, 1999
- Review
- 119 days
- Class
- Class I
- Product code
- CHH
- Recalls
- 1
- Predicates
- 0
10 later devices descend from it, 3 citing it directly.
- This deviceK990688 MTM Bioscanner C Test StripsPolymer Technology Systems, Inc. · 1999
- Descendant · cites it directly · 5 of its ownK023558 PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2002 · Recalled
- Descendant · cites it directly · 2 of its ownK071507 PTS Panels Chol+HDL+Glu Panel Test StripsPolymer Technology Systems, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 1 of its ownK090405 Lipidpro SystemInfopia Co, Ltd. · 2009
- Descendant · cites it directly · 1 of its ownK071593 PTS Panels Chol+HDL Panel Test StripsPolymer Technology Systems, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 0 of its ownK160282 SD LipidoCare Professional System, SD LipidoCare Home System, SD…Sd Biosensor · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K023558PTS Panels Lipid Panel Test StripsPolymer Technology Systems, Inc. · 2002 · cites it directly5descendants
- K071507PTS Panels Chol+HDL+Glu Panel Test StripsPolymer Technology Systems, Inc. · 2007 · cites it directly2descendants
- K090405Lipidpro SystemInfopia Co, Ltd. · 2009 · 2 generations on1descendant
- K071593PTS Panels Chol+HDL Panel Test StripsPolymer Technology Systems, Inc. · 2007 · cites it directly1descendant
- K160282SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT…Sd Biosensor · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990688 | MTM Bioscanner C Test Strips | Polymer Technology Systems, Inc. | 1999 | — |
| +1 | K023558 | PTS Panels Lipid Panel Test Strips | Polymer Technology Systems, Inc. | 2002 | 2 |
| +1 | K071507 | PTS Panels Chol+HDL+Glu Panel Test Strips | Polymer Technology Systems, Inc. | 2007 | 4 |
| +2 | K090405 | Lipidpro System | Infopia Co, Ltd. | 2009 | — |
| +1 | K071593 | PTS Panels Chol+HDL Panel Test Strips | Polymer Technology Systems, Inc. | 2007 | 1 |
| +2 | K160282 | SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT… | Sd Biosensor | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CHH? 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 CHH device
- #1 K251091 Lipidsscore 10.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 2, 2009 | Not classified | Z-0871-2010 | Process control | The memory chip was coded with incorrect product information. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023558 (Polymer Technology Systems, Inc., 2002) has gone furthest, with 5 descendants of its own.
How does its category compare?
All CHH devicesCHH Enzymatic Esterase--Oxidase, Cholesterol: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CHH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CHH
198in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CHH
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHH
14in 2025
MAUDE reports naming product code CHH, 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 | 2 | — | 0 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 3 | 0 |
| 2010 | 0 | — | 2 | 10 |
| 2011 | 1 | — | 0 | 18 |
| 2012 | 4 | 198 | 0 | 11 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 1 | — | 1 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 2 | 5 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 2 | 2 |
| 2022 | 1 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 14 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The MTM BioScanner C Test Strip is intended for the in-vitro-diagnostic quantitation of total Cholesterol in whole blood when used with the MTM BioScanner 1000. This system is intended to be used to assist the healthcare professional and the consumer in screening for elevated cholesterol as a risk factor in coronary artery disease.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990688: MTM Bioscanner C Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990688
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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