ClearanceBrief
Company ยท US

Enterix, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2017. Name variants (Inc, Corp, punctuation) are merged.

3510(k) clearances (0 in 12 months)
3recalls (1 in 12 months)
3recalls that name a 510(k)

Product codes

CodeDeviceRecords
KHEReagent, Occult Blood6

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 5, 2017K170548InSure ONE
Enterix, Inc.
KHE
May 4, 2006K060930INSURE II
Enterix, Inc.
KHE
Jan 12, 2001K002457!NSURE FECAL OCCULT BLOOD TEST
Enterix, Inc.
KHE

Latest recalls

DateFirm and productCodeLinked 510(k)
Nov 28, 2025Enterix, 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		 KHEK170548
Oct 8, 2020Enterix, 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		 KHEK170548
Dec 29, 2008Enterix, Inc.
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.
Terminated		 KHEK060930
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