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Fibreplast RT-A182KYSDN

by Qfix

Fibreplast RT-A182KYSDN is a Class II device made by Qfix, cleared under FDA 510(k) K935067 on 26 May 1994 and listed in FDA GUDID since 26 May 2026 (UDI-DI 00841962120562), active as of 22 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 22 Oct 2026

Documents

510(k) K935067

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00841962120562 UDI-DI Date26 May 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK935067 Date26 May 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K935067 decided 26 May 1994 Active
  • FDA GUDID UDI-DI 00841962120562 listed 26 May 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K935067
  2. Listed FDA GUDID 00841962120562

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Fibreplast
Generic name
Patient positioning thermoplastic mould material
Model / Ref / Catalog
RT-A182KYSDN
Primary DI / UDI-DI
00841962120562
510(k) Number
FDA product code
IYE
GMDN term
Patient positioning thermoplastic mould material
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Other devices from Qfix

See all devices from Qfix →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)