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Transcend EZEX System

by Somnetics International, Inc

Transcend EZEX System (503066) is a Class II device made by Somnetics International, Inc, cleared under FDA 510(k) K132127 on 17 Oct 2013 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI M9505030660), active as of 23 Oct 2026.

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

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) K132127

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 NumberM9505030660 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK132127 Date17 Oct 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132127 decided 17 Oct 2013 Active
  • FDA GUDID UDI-DI M9505030660 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132127
  2. Listed FDA GUDID M9505030660

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Transcend
Generic name
Home CPAP unit
Model / Ref / Catalog
EZEX System, 503066
Primary DI / UDI-DI
M9505030660
510(k) Number
FDA product code
BZD
GMDN term
Home CPAP unit
Device class
Class II
Regulation number
868.5905
GUDID distribution status
In Commercial Distribution
Size
Length — 11.5 Inch
Width — 9.5 Inch
Height — 4.5 Inch

Related devices

Category: Home CPAP unit

Cleared under the same submission (K132127)

and 8 more cleared under K132127

Similar devices

Other devices filed under FDA product code BZD (Ventilator, Non-Continuous (Respirator)).

Other devices from Somnetics International, Inc

See all devices from Somnetics International, Inc →

Properties

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