510(k) · Cleared
Recalled · Class II · 2025Derma Sciences Medihoney Dressings with Active Manuka Honey
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Derma Sciences, Inc. · FRO Dressing, Wound, Drug
Cleared on Apr 23, 2008 as substantially equivalent to K072956 (Derma Sciences, Inc., 2007) and 1 other predicate after a 77-day review. Its family tree reaches back 2 generations to 2007. 16 later devices descend from it. It has been recalled 3 times.
- Decided
- Apr 23, 2008
- Review
- 77 days
- Class
- Class U
- Product code
- FRO
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 2 generations to K053095 (2007). 16 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK053095 Honey Alginate DressingDerma Sciences Canada, Inc. · 2007 · Recalled
- 1 generation backK072956 Medihoney Primary Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2007
- This deviceK080315 Derma Sciences Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008
- Descendant · cites it directly · 14 of its ownK081584 Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008
- Descendant · 2 generations on · 10 of its ownK092689 Manukapli Wound DressingManuka Medical Limited · 2010
- Descendant · 3 generations on · 4 of its ownK121227 Manuka FillLinks Medical Products, Inc. · 2012
- Descendant · 4 generations on · 3 of its ownK131796 Manuka Fill Wound DressingLinks Medical Products, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 3 of its ownK102659 Manukahd, Manukahd Rope, Manukahd BorderManuka Medical Limited · 2010
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K081584Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008 · cites it directly14descendants
- K092689Manukapli Wound DressingManuka Medical Limited · 2010 · 2 generations on10descendants
- K121227Manuka FillLinks Medical Products, Inc. · 2012 · 3 generations on4descendants
- K131796Manuka Fill Wound DressingLinks Medical Products, Inc. · 2014 · 4 generations on3descendants
- K102659Manukahd, Manukahd Rope, Manukahd BorderManuka Medical Limited · 2010 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K053095 | Honey Alginate Dressing | Derma Sciences Canada, Inc. | 2007 | 1 |
| −1 | K072956 | Medihoney Primary Dressings with Active Manuka Honey | Derma Sciences, Inc. | 2007 | — |
| 0 (this device) | K080315 | Derma Sciences Medihoney Dressings with Active Manuka Honey | Derma Sciences, Inc. | 2008 | — |
| +1 | K081584 | Derma Sciences Otc Medihoney Dressings with Active Manuka Honey | Derma Sciences, Inc. | 2008 | — |
| +2 | K092689 | Manukapli Wound Dressing | Manuka Medical Limited | 2010 | — |
| +3 | K121227 | Manuka Fill | Links Medical Products, Inc. | 2012 | — |
| +4 | K131796 | Manuka Fill Wound Dressing | Links Medical Products, Inc. | 2014 | 1 |
| +2 | K102659 | Manukahd, Manukahd Rope, Manukahd Border | Manuka Medical Limited | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2026 | 1 | 0 |
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 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K072956 | Medihoney Primary Dressings with Active Manuka HoneySummary page 1…ame: Wound Dressing Classification Name: Dressing 3. PREDICATE DEVICES * Medihoney Primary Wound Dressings with Active Manuka Honey (K072956) * API-MED Active Manuka Honey Wound Dressings (K053095) 4. DEVICE DESCRIPTION Derma Sciences Medihoney Dressing… | 2007 |
| * | K053095 | Honey Alginate DressingSummary page 1…Dressing 3. PREDICATE DEVICES * Medihoney Primary Wound Dressings with Active Manuka Honey (K072956) * API-MED Active Manuka Honey Wound Dressings (K053095) 4. DEVICE DESCRIPTION Derma Sciences Medihoney Dressing with Active Manuka Honey are sterile, wound care dressing… | 2007 |
What descends from it? (16)
See all 164 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 5, 2025 | Class II | Z-2506-2025 | Under Investigation by firm | Packaging failures were identified which could lead to a breach in the sterile barrier. |
| Aug 5, 2025 | Class II | Z-2505-2025 | Under Investigation by firm | Packaging failures were identified which could lead to a breach in the sterile barrier. |
| Sep 13, 2024 | Class II | Z-0054-2025 | Under Investigation by firm | There is a potential for pinholes in the applicator pouch film which creates a sterility concern. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 1 year and passes through 2 companies; a new generation was cleared every 6 months on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K081584 (Derma Sciences, Inc., 2008) has gone furthest, with 14 descendants of its own.
- 5 other devices also cite its predicate K072956.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
What is it indicated for?
The Derma Sciences Medihoney Dressings with Active Manuka Honey provide a
moist environment conducive to wound healing and is indicated for the
management of light to moderately exuding wounds such as:
· 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, and traumatic and surgical wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080315: Derma Sciences Medihoney Dressings with Active Manuka Honey.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080315
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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