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SoClean SC1450

by Soclean, Inc. 4 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810030570011 UDI-DI Date10 Jun 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
SoClean
Generic Name
Home CPAP/BPAP ozone disinfector
Model / Ref / Catalog
SC1450, PN1457-3M
Primary DI / UDI-DI
00810030570011
510(k) Number
FDA Product Code
QXQ
GMDN Term
Home CPAP/BPAP ozone disinfector
Device Class
Class II
Regulation Number
880.6993
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K243815)

Other devices from Soclean, Inc.

Properties

  • Over-the-Counter
  • Convenience Kit
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No