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TRACOE® technic REF 730

by Tracoe medical GmbH

TRACOE technic REF 730, an endotracheal tube cuff inflator (FDA Class II; FDA product code BSK, Cuff, tracheal tube, inflatable) made by Tracoe medical GmbH, was cleared under FDA 510(k) K152865 on 27 Sep 2016 and listed in FDA GUDID on 23 Jan 2017 (UDI-DI 04035324019496); the registry lists it as not in commercial distribution (GUDID) as of 23 Oct 2026.

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 found

in data synced 23 Oct 2026

Documents

510(k) K152865

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 Number04035324019496 UDI-DI Date23 Jan 2017ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK152865 Date27 Sep 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K152865 decided 27 Sep 2016 Active
  • FDA GUDID UDI-DI 04035324019496 listed 23 Jan 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K152865
  2. Listed FDA GUDID 04035324019496

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TRACOE® technic
Generic name
Endotracheal tube cuff inflator
Model / reference
REF 730
Primary DI / UDI-DI
04035324019496
510(k) Number
FDA product code
BSK
GMDN term
Endotracheal tube cuff inflator
Device class
Class II
Regulation number
868.5750
GUDID distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe

Related devices

Cleared under the same submission (K152865)

Similar devices

Other devices filed under FDA product code BSK (Cuff, tracheal tube, inflatable).

Other devices from Tracoe medical GmbH

See all devices from Tracoe medical GmbH →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)