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SecureFoam 5036

by Bionix, LLC 3 variants

SecureFoam 5036, a radiological whole-body positioner (FDA Class II; FDA product code IYE, Accelerator, linear, medical) made by Bionix, LLC, was cleared under FDA 510(k) K040773 on 9 Apr 2004 and listed in FDA GUDID on 8 Aug 2022 (UDI-DI 00714646000347); the registry lists it as not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

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) K040773

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 Number00714646000347 UDI-DI Date8 Aug 2022ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK040773 Date9 Apr 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K040773 decided 9 Apr 2004 Active
  • FDA GUDID UDI-DI 00714646000347 listed 8 Aug 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K040773
  2. Listed FDA GUDID 00714646000347

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
SecureFoam
Generic name
Radiological whole-body positioner
Model / Ref / Catalog
5036
Primary DI / UDI-DI
00714646000347
510(k) Number
FDA product code
IYE
GMDN term
Radiological whole-body positioner
Device class
Class II
Regulation number
892.5050
GUDID distribution status
Not in Commercial Distribution
MRI safety
MR Safe

Related devices

Cleared under the same submission (K040773)

and 8 more cleared under K040773

Similar devices

Other devices filed under FDA product code IYE (Accelerator, linear, medical).

Other devices from Bionix, LLC

See all devices from Bionix, LLC →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)