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510(k) K190268

Hydrofera Blue READY - Border by Hydrofera, LLC — Product Code FRO

K190268 is an FDA 510(k) premarket notification submitted by Hydrofera, LLC for the device "Hydrofera Blue READY - Border". The FDA issued a decision of Substantially Equivalent on November 6, 2019. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Hydrofera, LLC has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2019
Date Received
February 8, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Hydrofera, LLC

  • K130670 — HYDROFERA BLUE PU BACTERIOSTATIC DRESSING (January 2, 2014)
  • K023138 — HYDROFERA BACTERIOSTATIC WOUND DRESSING (January 17, 2003)
  • K013462 — HYDROFERA BACTERIOSTATIC WOUND DRESSING (January 11, 2002)
  • K983276 — HYDROFERA BACTERISTATIC NASAL DRESSING (September 14, 1999)
  • K974313 — HYDROFERA SURGICAL SPEAR (March 2, 1998)
  • K974316 — HYDROFERA FEMORAL WICK (February 13, 1998)

Other clearances for product code FRO

  • K261023 — Microdacyn Wound Irrigation Solution (June 24, 2026)
  • K251929 — SilverCeuticals® Antimicrobial Wound Gel (June 24, 2026)
  • K261638 — Bonvadis® (June 17, 2026)
  • K254073 — StatSeal Disc (May 13, 2026)
  • K254191 — IWD-Gel™ (April 7, 2026)
  • K252023 — MiraChlor Antimicrobial Wound Solution (March 25, 2026)
  • K251999 — Promogran Prisma™ Collagen Matrix with ORC and Silver (March 13, 2026)
  • K252028 — LUOFUCON® Antimicrobial Wound Gel (March 11, 2026)
  • K251582 — Redermax Antibacterial Wound Matrix (February 2, 2026)
  • K252568 — New Day Skin Spray (January 23, 2026)

FDA data resources