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InSure ONE

by Enterix Inc.

510(k) K170548

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK170548 Date5 Oct 2017ClearedStatusActive

Official records

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0725-2026 FDA Class II initiated 17 Sep 2025

    InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results.

    • Terminated Z-0590-2021 FDA Class II initiated 8 Oct 2020

    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

Timeline

3 dated events

  1. Cleared FDA 510(k) K170548
  2. Recall initiated FDA recalls Z-0590-2021
  3. Recall initiated FDA recalls Z-0725-2026

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
KHE
FDA applicant
Enterix, Inc.
Device class
Class II
Regulation
21 CFR Part 864.6550
Advisory committee
Hematology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

InSure ONE is a Class II medical device that functions as a reagent for detecting occult blood in fecal samples using a lateral flow chromatographic immunoassay to measure human hemoglobin (hHb). It is designed for fecal sample collection and analysis in hematology applications.

The device is supplied as a single-use product and is regulated under FDA 510(k) clearance with product code KHE. It is stored at room temperature and is not indicated for MRI safety. The device has received FDA clearance as substantially equivalent for the purpose of modifying the fecal sample collection procedure.

Devices cleared under K170548

8 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K170548
UDI-DISize and differences
InSure® ONE™ 01
ENTERIX INC.
0100850093003316
Prescription: yes
On the market
InSure® ONE™ 01
ENTERIX INC.
0100850093003323
Prescription: no
On the market
InSure® ONE™ 01
ENTERIX INC.
11018.01 / 0100850093003286
Prescription: no
On the market
InSure® ONE™ 01
ENTERIX INC.
14103.01 / 0100850093003293
Prescription: no
On the market
InSure® ONE™ 01
ENTERIX INC.
80025.01 / 0100850093003231
Prescription: no
On the market
InSure® ONE™ 01
ENTERIX INC.
90002.01 / 0100850093003309
Prescription: no
On the market
InSure® ONE™ 01
ENTERIX INC.
90030.01 / 0100850093003279
Prescription: yes
On the market
InSure® ONE™ 01
ENTERIX INC.
90035.01 / 0100850093003354
Prescription: yes
On the market

Similar devices

Other devices filed under FDA product code KHE (Reagent, Occult Blood).

Other devices from Enterix Inc.

See all devices from Enterix Inc. →