510(k) Report

510(k) · Cleared

Cleared

Medihoney Wound Dressings

K133279510(k) TraditionalCleared Jun 25, 2015609-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Derma Sciences, Inc. · FRO Dressing, Wound, Drug

Cleared on Jun 25, 2015 as substantially equivalent to K080315 (Derma Sciences, Inc., 2008) after a 609-day review. Its family tree reaches back 3 generations to 2007.

Decided
Jun 25, 2015
Review
609 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K053095 (2007). No later device cites it as a predicate yet.

Reference device: K024054 · Xylos Xcell Antimicrobial Dressing · Xylos Corporation · 2003Reference device: K072068 · Bioaquacare, Model C-10( Various Sizes) with and Without Gauze, Blister Packaged or in Plastic Bag Containers · Bioartificial Gel Technologies (Bagtech), Inc. · 2007K053095 · Honey Alginate Dressing · Derma Sciences Canada, Inc. · 2007 · recalledK072956 · Medihoney Primary Dressings with Active Manuka Honey · Derma Sciences, Inc. · 2007K080315 · Derma Sciences Medihoney Dressings with Active Manuka Honey · Derma Sciences, Inc. · 2008 · recalled200620082010201220142016
K080315 · Derma Sciences Medihoney Dressings with Active Manuka Honey · Derma Sciences, Inc. · 2008 · recalledK072956 · Medihoney Primary Dressings with Active Manuka Honey · Derma Sciences, Inc. · 2007K053095 · Honey Alginate Dressing · Derma Sciences Canada, Inc. · 2007 · recalled0
  1. Root · 3 generations backK053095 Honey Alginate DressingDerma Sciences Canada, Inc. · 2007 · Recalled
  2. 2 generations backK072956 Medihoney Primary Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2007
  3. 1 generation backK080315 Derma Sciences Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008 · Recalled
  4. This deviceK133279 Medihoney Wound DressingsDerma Sciences, Inc. · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K053095Honey Alginate DressingDerma Sciences Canada, Inc.20071
−2K072956Medihoney Primary Dressings with Active Manuka HoneyDerma Sciences, Inc.2007—
−1K080315Derma Sciences Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc.20083
0 (this device)K133279Medihoney Wound DressingsDerma Sciences, Inc.2015—
FIG. 1 — Lineage of K133279, 2007–2015Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FRO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FRO device

  1. #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K080315Derma Sciences Medihoney Dressings with Active Manuka Honey
Summary page 6
…K133279, page 2 of 6 3. PREDICATE DEVICES Derma Sciences believes the primary Medihoney Dressing predicate is the following based on general to specific use. K080315 Derma Sciences Medihoney Dressings with Active Manuka Honey (Dressing with Active Leptospermum Honey) Reference predicates a…
Derma Sciences, Inc.20083
†K024054Xylos Xcell Antimicrobial DressingXylos Corporation2003—
†K072068Bioaquacare, Model C-10( Various Sizes) with and Without Gauze, Blister Packaged or in…Bioartificial Gel Technologies (Bagtech), Inc.2007—

Also cleared against K080315: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 6 months on median.
  • 2 of the 3 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K080315.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · FRO

11in 2025

2007: 292008: 262009: 312010: 312011: 272012: 242013: 192014: 222015: 282016: 282017: 232018: 202019: 162020: 122021: 82022: 92023: 182024: 242025: 112026 (partial year): 17
2007high 31 (2009) · low 8 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRO

176in 2025

2007: 187 days median2008: 130 days median2009: 136 days median2010: 146 days median2011: 177 days median2012: 96 days median2013: 194 days median2014: 214 days median2015: 249 days median2016: 222 days median2017: 147 days median2018: 206 days median2019: 270 days median2020: 226 days median2021: 275 days median2022: 332 days median2023: 283 days median2024: 263 days median2025: 176 days median2026 (partial year): 254 days median
2007high 332 (2022) · low 96 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRO

2in 2024

2007: 42008: 12009: 12011: 42013: 12014: 12015: 22016: 32017: 12019: 12021: 62022: 22023: 2, 2 Class I2024: 22026 (partial year): 2
2007high 6 (2021) · low 0 (2010)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · FRO

192in 2025

2007: 552008: 302009: 452010: 1222011: 422012: 652013: 1392014: 2692015: 2972016: 1472017: 1492018: 1282019: 1362020: 1392021: 1832022: 1762023: 1982024: 2322025: 192
2007high 297 (2015) · low 30 (2008)2025

MAUDE reports naming product code FRO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200729187455
200826130130
200931136145
2010311460122
201127177442
20122496065
2013191941139
2014222141269
2015282492297
2016282223147
2017231471149
2018202060128
2019162701136
2020122260139
202182756183
202293322176
2023182832 (2)198
2024242632232
2025111760192
2026172542—

What is it indicated for?

Medihoney Calcium Alginate Dressing with Active Leptospermum Honey are indicated for the management of moderate to heavily exuding wounds by providing a moist environment, which is conducive to wound healing, and supports and aids autolytic debridement. These dressings are intended for the management of the following: • Diabetic foot ulcers • Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) • Pressure ulcers/sores…

Read the full statement (437 words)

Medihoney Calcium Alginate Dressing with Active Leptospermum Honey are indicated for the management of moderate to heavily exuding wounds by providing a moist environment, which is conducive to wound healing, and supports and aids autolytic debridement. These dressings are intended for the management of the following:

• Diabetic foot ulcers

• Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)

• Pressure ulcers/sores (partial and full thickness)

• 1st and 2nd degree partial thickness burns

• donor sites

• traumatic and surgical wounds

Medihoney Adhesive and Non-Adhesive Honeycolloid Dressings with Active Leptospermum Honey are indicated for the management of light to moderately exuding wounds by providing a moist environment, which is conducive to wound healing, and supports and aids autolytic debridement. These dressings are intended for the management of the following:

• Diabetic foot ulcers

• Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)

• Pressure ulcers/sores (partial and full thickness)

• 1st and 2nd degree partial thickness burns

• donor sites

• traumatic and surgical wounds

Medihoney Dressings with Active Leptospermum Honey are indicated for the management of light to moderately exuding wounds by providing a moist environment, which is conducive to wound healing, and supports and aids autolytic debridement. These dressings are intended for the management of the following:

• Diabetic foot ulcers

• Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)

• Pressure ulcers/sores (partial and full thickness)

• 1st and 2nd degree partial thickness burns

• donor sites

• traumatic and surgical wounds

Medihoney Gel Dressing with Active Leptospermum Honey are indicated for the management of light to moderately exuding wounds by providing a moist environment, which is conducive to wound healing, and supports and aids autolytic debridement. These dressings are intended for the management of the following:

• Diabetic foot ulcers

• Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)

• Pressure ulcers/sores (partial and full thickness)

• 1st and 2nd degree partial thickness burns

• donor sites

• traumatic and surgical wounds

The Medihoney Adhesive and Non-Adhesive Hydrogel Colloidal Sheet with Leptospermum Honey are indicated for the management of non-draining to lightly exuding wounds by providing a moist environment, which is conducive to wound healing, and supports and aids autolytic debridement. These dressings are intended for the management of the following:

• Diabetic foot ulcers

• Leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology)

• Pressure ulcers/sores (partial and full thickness)

• 1st and 2nd degree partial thickness burns

• donor sites

• traumatic and surgical wounds

Indications for use as stated in the FDA summary.

Also cleared against K080315

3 other devices cite the same predicate.

  • K101114Advancis Activon TubeAdvancis Medical · 2011
  • K101793Medihoney Gel Dressing with Active Manuka HoneyDerma Sciences, Inc. · 20114 recalls
  • K081584Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008

More from Derma Sciences, Inc.

22 FDA decisions under this applicant name. See the company

  • K150985Medihoney Wound GelDerma Sciences, Inc. · 20151 recall
  • 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

Recent decisions in FRO

The FRO category page

  • K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH · 2026
  • K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC · 2026
  • K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026
  • K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC · 2026
  • K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc. · 2026

https://510kreport.com/device/K133279 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133279: Medihoney Wound Dressings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133279

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026