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Vt-0401-50

by Summit Medical, LLC

Vt-0401-50, a tympanostomy tube (FDA Class II; FDA product code ETD, Tube, Tympanostomy) made by Summit Medical, LLC, was cleared under FDA 510(k) K830228 on 7 Mar 1983 and listed in FDA GUDID on 12 Sep 2016 (UDI-DI 00385640001090); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026. FDA recalls on record: 1.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K830228

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00385640001090 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK830228 Date7 Mar 1983DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K830228 decided 7 Mar 1983 Active
  • FDA GUDID UDI-DI 00385640001090 listed 12 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1731-2014 FDA Class II initiated 12 May 2014

    One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. This poses no health hazard to the user or patient.

Timeline

3 dated events

  1. Cleared FDA 510(k) K830228
  2. Recall initiated FDA recalls Z-1731-2014
  3. Listed FDA GUDID 00385640001090

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Tympanostomy tube
Model / reference
VT-0401-50
Primary DI / UDI-DI
00385640001090
510(k) Number
FDA product code
ETD
GMDN term
Tympanostomy tube
Device class
Class II
Regulation number
874.3880
GUDID distribution status
Not in Commercial Distribution
MRI safety
MR Conditional

Related devices

Cleared under the same submission (K830228)

and 8 more cleared under K830228

Similar devices

Other devices filed under FDA product code ETD (Tube, Tympanostomy).

Other devices from Summit Medical, LLC

See all devices from Summit Medical, LLC →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)