Data / Medical devices / United States / Enterix Inc.
Enterix Inc.: FDA-registered device maker in Edison, NJ, United States, 2 510(k) clearances
Enterix Inc. is registered with the FDA (registration 1226769) in Edison, NJ, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 5, 2017. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1226769
- FEI number
- 3003224146
- Address
- 236 Fernwood Ave, Edison, NJ, United States, 08837
- Owner or operator
- 3T MEDICAL SYSTEMS, Inc (9043935)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 3, 2024
- Registered through
- 2026
- Brand names listed
- InSure One
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Control, Fecal Occult Blood | OSL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Reagent, Occult Blood | KHE | 2 | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 5, 2017 | K170548 | InSure ONE | KHE | Substantially Equivalent | Enterix, Inc. | accessdata.fda.gov |
| October 1, 2010 | K101831 | ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 | OSL | Substantially Equivalent | Bionostics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 17, 2025 | 97802 | Class II | Ongoing | 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 POL Combo Pack. Model Nu | InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results. | accessdata.fda.gov |
| October 8, 2020 | 86674 | Class II | Terminated | InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT) qualitatively detects human hemoglobin from blood in fecal samples Model 12045.01. | Product does not meet internal testing criterion; use of the product may result in a potential false positive test result and may lead to patients undergoing unnecessary follow-up diagnostic procedure, i.e., colonoscopy or sigmoidoscopy | accessdata.fda.gov |
| October 3, 2008 | 49560 | Not yet classified | Terminated | INSURE(R) QUIK FIT(TM) DEVELOPER KIT, Lot number B1478, Product Numbers: 30025 (InSure Quik FIT Developer Kit) and 50025 (INSURE(R) QUIK FIT(TM) containing Developer Kit and Patient Collection Kits. Product Number 30025 | False readings: Reduced sensitivity could affect the test line area and/or control line on the test strips, which may lead to inaccurate results. For further information, please contact Enterix, Inc. at 1-800-531--3681. | accessdata.fda.gov |
Compare with other makers
Updated November 28, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.