510(k) Report

FDA applicant

Derma Sciences, Inc.

Old Forge, PA22 decisions1992–201513 recalls

FDA records 22 decisions for Derma Sciences, Inc. (Old Forge, PA) from 1992 to 2015: 22 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and KMF (Bandage, Liquid). Its devices cite 24 predicates, 14 of them its own earlier devices. 13 recalls are linked to its devices.

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

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Derma Sciences, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2007: 12008: 22011: 22015: 2
2007high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

2in 2026

2018: 12022: 12024: 12025: 82026 (partial year): 2
2007high 8 (2025) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Derma Sciences, Inc.’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, Drug12decisions
  • KMFBandage, Liquid5decisions
  • MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic4decisions
  • MGPDressing, Wound And Burn, Occlusive1decision

Whose devices does it build on?

Its devices cite 24 predicates; 14 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 35 times; 14 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.

  • K945802Dermagran Wound Cleanser with ZincDerma Sciences, Inc. · 19957cite it
  • K072956Medihoney Primary Dressings with Active Manuka HoneyDerma Sciences, Inc. · 20076cite it
  • K081584Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 20084cite it
  • K080315Derma Sciences Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 20084cite it
  • K954743Dermagran Wound Dressing Cleaner W/ZincDerma Sciences, Inc. · 19953cite it
  • K970660Dermagran Wound Management SystemDerma Sciences, Inc. · 19972cite it

What has FDA decided for it lately?

  • K150985Medihoney Wound GelDerma Sciences, Inc. · 20151 recall
  • K133279Medihoney Wound DressingsDerma Sciences, Inc. · 2015
  • K110546Medihoney Hydrogel Sheet Dressings with Active Leptospermum HoneyDerma Sciences, Inc. · 20115 recalls
  • K101793Medihoney Gel Dressing with Active Manuka HoneyDerma Sciences, Inc. · 20114 recalls
  • K081584Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008
  • K080315Derma Sciences Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 20083 recalls
  • K072956Medihoney Primary Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2007
  • K970660Dermagran Wound Management SystemDerma Sciences, Inc. · 1997

All 22 as Derma Sciences, Inc. →

What has been recalled?

13 recalls linked to its devices; the latest:

  • K101793MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2)…Jan 16, 2026Class II
  • K150985Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment…Jan 16, 2026Class II
  • K080315Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number: 31515 and…Aug 5, 2025Class II
  • K110546Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dressing…Aug 5, 2025Class II
  • K110546Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Number: 31620…Aug 5, 2025Class II
  • K110546Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Model/Catalog…Aug 5, 2025Class II

Other applicant names beginning “Derma”

FDA records each applicant name separately; these may or may not be the same firm.

Derma Media Lab., Inc. 18Derma-Lase Co. 5Derma Sciences Canada, Inc. 3Derma-Lock Medical Corp. 2Derma-Safe Co. 2Derma Care Plus Products, LLC 2