# K022755: Lifeguard

- Pathway: 510(k) (Traditional)
- Applicant: Medtek, LLC
- Decided: Sep 24, 2002 after 35 days
- Product code: KHE (Reagent, Occult Blood)
- Device class: 2
- Regulation: 21 CFR 864.6550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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.

Source page: https://510kreport.com/device/K022755
Methodology: https://510kreport.com/methodology