Skip to content

Ultracell Ear Wick

by Ultracell Medical Technologies, Inc.

510(k) K920357

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

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK920357 Date1 Feb 1993ClearedStatusActive

Recalls

6 recalls · 1 ongoing · FDA

    • Ongoing Z-1625-2022 FDA Class II initiated 25 May 2022

    Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

  • 5 recalls, same reason

    • Terminated Z-0480-03 FDA Unclassified (pre-2012) initiated 8 Jan 2003
    • Terminated Z-0485-03 FDA Unclassified (pre-2012) initiated 8 Jan 2003
    • Terminated Z-0481-03 FDA Unclassified (pre-2012) initiated 8 Jan 2003
    • Terminated Z-0483-03 FDA Unclassified (pre-2012) initiated 8 Jan 2003
    • Terminated Z-0482-03 FDA Unclassified (pre-2012) initiated 8 Jan 2003

    Sterility of the device is compromised

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  • Withdrawn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
KCN
Device Class
Class I
Regulation
21 CFR Part 874.5220
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Other devices from Ultracell Medical Technologies, Inc.

See all devices from Ultracell Medical Technologies, Inc. →