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Klarity Medical R550-OA1

by Klarity Medical Products, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840510401627 UDI-DI Date5 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-2881-2020 FDA Class II initiated 31 Jul 2020

    Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Klarity Medical
Generic Name
Patient positioning foam mould kit
Model / Reference
R550-OA1
Primary DI / UDI-DI
00840510401627
510(k) Number
FDA Product Code
IYE
GMDN Term
Patient positioning foam mould kit
Device Class
Class II
Regulation Number
892.5050
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Related devices

Cleared under the same submission (K132124)

Show all (12)

Other devices from Klarity Medical Products, LLC

See all devices from Klarity Medical Products, LLC →

Properties

  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No