510(k) Report

FDA applicant

Hydrofera, LLC

Willimantic, CT7 decisions1998–20190 recalls

FDA records 7 decisions for Hydrofera, LLC (Willimantic, CT) from 1998 to 2019: 7 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and EFQ (Gauze/Sponge, Internal). Its devices cite 4 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ear, nose and throat panel, where it files most

How often FDA has decided Hydrofera, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2014: 12019: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Hydrofera, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Hydrofera, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FRODressing, Wound, Drug4decisions
  • EFQGauze/Sponge, Internal1decision
  • EMXBalloon, Epistaxis1decision
  • HOZSponge, Ophthalmic1decision

Whose devices does it build on?

Its devices cite 4 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K983276Hydrofera Bacteristatic Nasal DressingHydrofera, LLC · 19992cite it
  • K013462Hydrofera Bacteriostatic Wound DressingHydrofera, LLC · 20022cite it
  • K130670Hydrofera Blue PU Bacteriostatic DressingHydrofera, LLC · 20141cites it

What has FDA decided for it lately?

  • K190268Hydrofera Blue READY - BorderHydrofera, LLC · 2019
  • K130670Hydrofera Blue PU Bacteriostatic DressingHydrofera, LLC · 2014
  • K023138Hydrofera Bacteriostatic Wound DressingHydrofera, LLC · 2003
  • K013462Hydrofera Bacteriostatic Wound DressingHydrofera, LLC · 2002
  • K983276Hydrofera Bacteristatic Nasal DressingHydrofera, LLC · 1999
  • K974313Hydrofera Surgical SpearHydrofera, LLC · 1998
  • K974316Hydrofera Femoral WickHydrofera, LLC · 1998

All 7 as Hydrofera, LLC →