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Transcend 365 miniCPAP Service Unit

by Somnetics International, Inc

Transcend 365 miniCPAP Service Unit (503101) is a Class II device made by Somnetics International, Inc, cleared under FDA 510(k) K180388 on 30 Nov 2018 and listed in FDA GUDID since 31 Dec 2019 (UDI-DI M9505031010), 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) K180388

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 NumberM9505031010 UDI-DI Date31 Dec 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK180388 Date30 Nov 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K180388 decided 30 Nov 2018 Active
  • FDA GUDID UDI-DI M9505031010 listed 31 Dec 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K180388
  2. Listed FDA GUDID M9505031010

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  • Withdrawn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
365 miniCPAP Service Unit, 503101
Primary DI / UDI-DI
M9505031010
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
Height — 4.5 Inch
Width — 3.8 Inch
Length — 7.8 Inch

Related devices

Category: Home CPAP unit

Cleared under the same submission (K180388)

and 6 more cleared under K180388

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)