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Hydrofera Blue HBRF4475

by Hydrofera, LLC

Hydrofera Blue HBRF4475 is a device classified as Unclassified made by Hydrofera, LLC, cleared under FDA 510(k) K013462 on 11 Jan 2002 and listed in FDA GUDID since 1 Jun 2018 (UDI-DI 20854827008145), 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) K013462

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 Number20854827008145 UDI-DI Date1 Jun 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK013462 Date11 Jan 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K013462 decided 11 Jan 2002 Active
  • FDA GUDID UDI-DI 20854827008145 listed 1 Jun 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K013462
  2. Listed FDA GUDID 20854827008145

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Hydrofera Blue
Generic name
Wound-nonadherent dressing, permeable, antimicrobial
Model / reference
HBRF4475
Primary DI / UDI-DI
20854827008145
510(k) Number
FDA product code
FRO
GMDN term
Wound-nonadherent dressing, permeable, antimicrobial
Device class
U
GUDID distribution status
In Commercial Distribution
Size
Height — 4.0 Inch
Width — 4.75 Inch

Related devices

Category: Wound-nonadherent dressing, permeable, antimicrobial

Cleared under the same submission (K013462)

and 8 more cleared under K013462

Similar devices

Other devices filed under FDA product code FRO (Dressing, Wound, Drug).

Other devices from Hydrofera, LLC

See all devices from Hydrofera, LLC →

Properties

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