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General product information only, not medical advice. Wound care decisions belong to a qualified healthcare professional, and this page contains no instructions for use.
Short answer
Medihoney is a brand name for a family of honey-based wound dressings made by Derma Sciences. The FDA cleared the family through the 510(k) pathway in a series of decisions from 2007 to 2015 under product code FRO, "Dressing, Wound, Drug". The main ingredient in each form is manuka (Leptospermum) honey, combined with alginate or hydrogel in some forms. "Cleared" is not "approved".
Definition and scope
In the FDA filings, "Medihoney" names a product line, not a type of honey. The 2015 510(k) summary (K133279) states that "the primary component of the Medihoney Family of Dressings is Active Manuka Honey", and that the dressings are provided sterile to the user. Older filings say "Active Manuka Honey"; newer ones say "Active Leptospermum Honey". These are the same descriptor in different eras of the paperwork.
In this record, a medical honey dressing (or honey dressing) is a wound dressing containing honey, filed under FDA product code FRO. Honey sold as food is outside this scope.
How honey dressings are described in practice
The FDA summaries describe what the dressings are intended to do, not how to apply them. For the alginate and gel forms, the 2015 summary says the material forms a gel as wound fluid (exudate) is absorbed, maintaining a moist environment. The calcium alginate indication reads: "management of moderate to heavily exuding wounds by providing a moist environment, which is conducive to wound healing, and supports and aids autolytic debridement". The 2015 change added autolytic debridement as a more specific statement of an existing function; the summary says mechanism of action, intended environment and functionality are identical to the original Medihoney dressings.
The wound types named in the K133279 indications are diabetic foot ulcers, leg ulcers (venous stasis, arterial and mixed), pressure ulcers (partial and full thickness), first and second degree partial thickness burns, donor sites, and traumatic and surgical wounds. This page does not give use instructions; the manufacturer’s instructions for use and a clinician govern use.
Types: the five Medihoney forms in the 2015 FDA summary
Every row below comes from the K133279 510(k) summary. The exudate level is the one stated in the form’s indication.
| Form | Composition (as listed) | Exudate level in the indication |
|---|---|---|
| Calcium Alginate Dressing | 95% Active Manuka Honey, 5% calcium alginate | Moderate to heavily exuding |
| Honeycolloid Dressing (adhesive and non-adhesive) | 80% Active Manuka Honey, 20% sodium alginate powder | Light to moderately exuding |
| Dressing with Active Leptospermum Honey (tube) | 100% Active Manuka Honey | Light to moderately exuding |
| Gel Dressing | 80% Active Manuka Honey, 15% myristyl myristate, 5% Plantacare 810 | Light to moderately exuding |
| Hydrogel Colloidal Sheet (with or without adhesive border) | 63% Leptospermum honey with hydrogel | Non-draining to lightly exuding |
The honey percentage is not constant: it ranges from 63% to 100% across the five forms, so "Medihoney" alone does not tell you the honey content of a given product.
Where it matters for labs, clinics and supply decisions
Regulatory trail
openFDA lists these 510(k) decisions for Derma Sciences under product code FRO, all with the decision "Substantially Equivalent":
- K053095, 12 July 2007: honey alginate dressing (cited in the K133279 summary among the original dressings whose instructions for use are identical)
- K072956, 7 November 2007: Medihoney primary dressings with active manuka honey (also cited in the K133279 summary)
- K080315, 23 April 2008: Medihoney dressings with active manuka honey (also cited in the K133279 summary)
- K081584, 19 June 2008: OTC Medihoney dressings with active manuka honey
- K101793, 22 February 2011: Medihoney gel dressing
- K110546, 27 July 2011: Medihoney hydrogel sheet dressings
- K133279, 25 June 2015: Medihoney wound dressings (the family summary used above)
- K150985, 19 November 2015: Medihoney Wound Gel
The K133279 decision letter lists the regulatory class as "Unclassified". A 510(k) clearance means the FDA found the device substantially equivalent to a legally marketed device and subject to the general controls of the Act. See the CASRAI entry on the Medical Device Amendments of 1976 for the background to that pathway, and FDA De Novo classification for the route used when no predicate exists.
Sterile versus non-sterile
The family summary states the dressings are provided sterile. The Medihoney Wound Gel summary (K150985) differs: the gel is to be gamma irradiated at 25-45 kGy but "will not be claimed sterile", and its formulation adds sodium benzoate as a preservative. For what a sterility claim means in numbers, see Sterility Assurance Level (SAL).
Over-the-counter versus supervised use
The hydrogel sheet summary (K110546) lists over-the-counter use for minor abrasions, minor cuts, minor scalds and minor burns, and other listed conditions "under the supervision of a healthcare professional". The Wound Gel summary lists over-the-counter use for minor abrasions, lacerations, minor cuts, minor scalds and burns. The indications therefore differ by form, as the sources state.
How it relates to other dressing categories
For related dressing categories, see hydrocolloid wound care; for a different wound-management device, see what a wound vac is.
Common misunderstandings
- "FDA-approved honey." These dressings were cleared by 510(k) substantial equivalence and are listed as unclassified. Clearance is a different regulatory finding from approval.
- "Medihoney is pure honey." Only one listed form is 100% honey; the others combine honey with alginate, hydrogel or gel ingredients.
- "All honey dressings are sterile." The Wound Gel is not claimed sterile, as noted above.
- "Medical honey is a grocery-store product." In the FDA record, a honey dressing is a wound dressing with its own clearance, composition and indications.
FAQ
What is Medihoney?
A brand of FDA-cleared honey wound dressings from Derma Sciences, built around manuka (Leptospermum) honey and offered as alginate, colloid, gel, tube and hydrogel sheet forms.
What is a honey dressing?
A wound dressing in which honey is the main active component, sometimes combined with alginate or hydrogel. The Medihoney forms in the 2015 FDA summary contain 63% to 100% honey.
What is a medical honey dressing?
A wound dressing containing honey. The Medihoney dressings were cleared under product code FRO, "Dressing, Wound, Drug", as unclassified devices.
Sources
Sources checked 30 October 2026.
- FDA 510(k) K133279, Medihoney Wound Dressings, decision letter and 510(k) summary: https://www.accessdata.fda.gov/cdrh_docs/pdf13/K133279.pdf
- FDA 510(k) K110546, Medihoney Hydrogel Sheet Dressings summary: https://www.accessdata.fda.gov/cdrh_docs/pdf11/K110546.pdf
- FDA 510(k) K150985, Medihoney Wound Gel summary: https://www.accessdata.fda.gov/cdrh_docs/pdf15/K150985.pdf
- openFDA device 510(k) and classification records, product code FRO: https://open.fda.gov/apis/device/510k/
