510(k) Report

FDA applicant

The Hymed Group Corp.

Bethlehem, PA6 decisions1996–20140 recalls

FDA records 6 decisions for The Hymed Group Corp. (Bethlehem, PA) from 1996 to 2014: 6 510(k) clearances. Most are in product codes MGQ (Dressing, Wound And Burn, Hydrogel W/Drug…) and FRO (Dressing, Wound, Drug). Its devices cite 5 predicates, 1 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

How often FDA has decided The Hymed Group Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 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 — The Hymed Group Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic2decisions
  • FRODressing, Wound, Drug2decisions
  • KGNWound Dressing With Animal-Derived Material (S)2decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 1 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.

  • K955506HycureThe Hymed Group Corp. · 19964cite it
  • K061227Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp. · 20062cite it
  • K961930ChondroprotecThe Hymed Group Corp. · 19961cites it
  • K994339Hycure Oral / Hycure Oral Smart GelThe Hymed Group Corp. · 20001cites it

What has FDA decided for it lately?

  • K132891Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp. · 2014
  • K061227Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp. · 2006
  • K994339Hycure Oral / Hycure Oral Smart GelThe Hymed Group Corp. · 2000
  • K961930ChondroprotecThe Hymed Group Corp. · 1996
  • K960686HycoatThe Hymed Group Corp. · 1996
  • K955506HycureThe Hymed Group Corp. · 1996

All 6 as The Hymed Group Corp. →