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Microtech Summit I2400 Ite

by Starkey Laboratories Inc. 2 variants

Microtech Summit I2400 Ite (K1I) is a Class II device made by Starkey Laboratories Inc., listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00842318110039), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00842318110039 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Microtech
Generic name
Air-conduction hearing aid, in-the-ear
Model / Ref / Catalog
SUMMIT I2400 ITE, K1I
Primary DI / UDI-DI
00842318110039
FDA product code
KLW, OSM
GMDN term
Air-conduction hearing aid, in-the-ear
Device class
Class II
Regulation number
874.3400, 874.3305
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Air-conduction hearing aid, in-the-earTinnitus masking application software

Other devices from Starkey Laboratories Inc.

See all devices from Starkey Laboratories Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)