510(k) K170548 ยท KHE Reagent, Occult Blood
InSure ONE
| Applicant | Enterix, Inc., Edison NJ, US |
| Decision | Substantially Equivalent, Oct 5, 2017 |
| Received | Feb 24, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170548
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 28, 2025 | Enterix, Inc. InSure ONE Fecal Immunochemical Test. Labeled as follows:
1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010.
2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025.
3. InSure ONE P Open, Classified |
KHE | None listed |
| Oct 8, 2020 | Enterix, Inc. InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01. Terminated |
KHE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.