Cleared Traditional

K170548 - InSure ONE

K170548 is the FDA 510(k) clearance for InSure ONE by Enterix, Inc.. It is a Class 2 Hematology device (product code KHE) cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K170548 · Enterix, Inc. · Hematology device
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Oct 2017
Decision
223d
Days
Class 2
Risk

K170548 is an FDA 510(k) clearance for the InSure ONE. Classified as Reagent, Occult Blood (product code KHE), Class II - Special Controls.

Submitted by Enterix, Inc. (Edison, US). The FDA issued a Cleared decision on October 5, 2017 after a review of 223 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6550 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Enterix, Inc. devices

Submission Details

510(k) Number K170548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2017
Decision Date October 05, 2017
Days to Decision 223 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 113d · This submission: 223d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHE Reagent, Occult Blood
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - KHE Reagent, Occult Blood

All 28
Devices cleared under the same product code (KHE) and FDA review panel - the closest regulatory comparables to K170548.
Instant-view-PLUS immunochemical Fecal Occult Blood Test
K173212 · Alfa Scientific Designs, Inc. · Feb 2018
Wondfo One Step Fecal Occult Blood (FOB) Test
K162333 · Guangzhou Wondfo Biotech Co., Ltd. · May 2017
BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST
K100817 · Princeton BioMeditech Corp. · Jul 2010
HEMOCCULT ICT
K080812 · Beckman Coulter, Inc. · Jun 2008
INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST
K070660 · Alfa Scientific Designs, Inc. · Jun 2007
FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLOOD CARD KIT, MODEL F735-25
K061065 · Teco Diagnostics · Jul 2006