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InSure® ONE™ 01

by Enterix Inc. 8 variants

InSure® ONE™ 01 (80025.01) is a Class II device made by Enterix Inc., cleared under FDA 510(k) K170548 on 5 Oct 2017 and listed in FDA GUDID since 5 Jan 2018 (UDI-DI 00850093003231), active as of 22 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

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

510(k) K170548

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850093003231 UDI-DI Date5 Jan 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170548 Date5 Oct 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170548 decided 5 Oct 2017 Active
  • FDA GUDID UDI-DI 00850093003231 listed 5 Jan 2018 Listed

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

4 dated events

  1. Cleared FDA 510(k) K170548
  2. Listed FDA GUDID 00850093003231
  3. Recall initiated FDA recalls Z-0590-2021
  4. 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  • Withdrawn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

GUDID

Trade name
InSure® ONE™
Generic name
Faecal occult blood IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
01, 80025.01
Primary DI / UDI-DI
00850093003231
510(k) Number
FDA product code
KHE
GMDN term
Faecal occult blood IVD, kit, rapid ICT, clinical
Device class
Class II
Regulation number
864.6550
GUDID distribution status
In Commercial Distribution

Related devices

Category: Faecal occult blood IVD, kit, rapid ICT, clinical

Cleared under the same submission (K170548)

and 3 more cleared under K170548

Similar devices

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

Other devices from Enterix Inc.

See all devices from Enterix Inc. →

Properties

  • Single use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)