510(k) · Cleared
ClearedLifestream Plus Cholesterol Monitor, Modification to Resolution Cholesterol Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lifestream Technologies, Inc. · NFX Test, Cholesterol, Total, Over The Counter
Cleared on May 20, 2004 after a 155-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 20, 2004
- Review
- 155 days
- Class
- Class I
- Product code
- NFX
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 NFX? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All NFX devicesNFX Test, Cholesterol, Total, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NFX
FDA has decided no NFX device since 2007.
Median 510(k) review, days · NFX
Too few NFX 510(k)s in any year since 2007 to give a median.
Recalls per year · NFX
No recall names NFX since 2007.
Adverse event reports per year · NFX
1in 2008
MAUDE reports naming product code NFX, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Lifestream Cholesterol Monitor is an over-the-counter in vitro diagnostic device for the measurement of total cholesterol in fingerstick whole blood samples. Total cholesterol measurements aid in the detection of persons who may be at risk for coronary heart disease, and provide information for individuals who are attempting to lower their levels through diet and exercise, or who are under a physician's care with lipid lowering drugs.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K033899 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033899: Lifestream Plus Cholesterol Monitor, Modification to Resolution Cholesterol Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033899
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026