510(k) · Cleared
ClearedLifeguard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtek, LLC · KHE Reagent, Occult Blood
Cleared on Sep 24, 2002 after a 35-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 24, 2002
- Review
- 35 days
- Class
- Class II
- Product code
- KHE
- 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 KHE? 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 KHE devicesKHE Reagent, Occult Blood: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KHE
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · KHE
126in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KHE
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHE
3in 2025
MAUDE reports naming product code KHE, 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 | 3 | 104 | 0 | 3 |
| 2008 | 3 | 93 | 1 | 5 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 2 | — | 6 | 4 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 0 | — | 2 | 16 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 1 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 4 | 126 | 0 | 1 |
| 2018 | 1 | — | 1 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 1 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 2 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LifeGuardTM is a guaiac-based test for the qualitative detection of occult blood in stool, which may indicate gastrointestinal disease. Patients can purchase the test without a prescription from stores or Internet distributors in order to perform testing at home. Users obtain their own stool samples by wiping onto the test device, then develop the tests, read the test results, and send a report of the results to their physician. LifeGuardTM is useful…
Read the full statement (134 words)
The LifeGuardTM is a guaiac-based test for the qualitative detection of occult blood in stool, which may indicate gastrointestinal disease. Patients can purchase the test without a prescription from stores or Internet distributors in order to perform testing at home. Users obtain their own stool samples by wiping onto the test device, then develop the tests, read the test results, and send a report of the results to their physician. LifeGuardTM is useful as an aid in the diagnosis of a number of gastrointestinal disorders and is used for colorectal cancer screening programs. The American Cancer Society recommends that at least three consecutive bowel movements be tested due to the irregularity of bleeding from some intestinal lesions. Therefore, the LifeGuardTM home test kit includes three test wipes for testing three closely spaced bowel movements.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K022755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022755: Lifeguard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022755
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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