510(k) · Cleared
Recalled · Class II · 2025Medihoney Hydrogel Sheet Dressings with Active Leptospermum 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 Jul 27, 2011 as substantially equivalent to K072956 (Derma Sciences, Inc., 2007) and 1 other predicate after a 152-day review. Its family tree reaches back 2 generations to 1987. 1 later device descends from it. It has been recalled 5 times.
- Decided
- Jul 27, 2011
- Review
- 152 days
- Class
- Class U
- Product code
- FRO
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 2 generations to K872165 (1987). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK872165 Elasto-Gel Occlusive DressingSouthwest Technologies, Inc. · 1987 · Recalled
- 1 generation backK053613 L-Mesitran Hydro, L-Mesitran Border, L-Mesitran Net, L-Mesitran ActiveTheo Manufacturing BV · 2007
- This deviceK110546 Medihoney Hydrogel Sheet Dressings with Active Leptospermum HoneyDerma Sciences, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK222143 Apis (R), Veris (TM)Sweetbio, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K222143Apis (R), Veris (TM)Sweetbio, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K872165 | Elasto-Gel Occlusive Dressing | Southwest Technologies, Inc. | 1987 | 2 |
| −1 | K053613 | L-Mesitran Hydro, L-Mesitran Border, L-Mesitran Net, L-Mesitran Active | Theo Manufacturing BV | 2007 | — |
| 0 (this device) | K110546 | Medihoney Hydrogel Sheet Dressings with Active Leptospermum Honey | Derma Sciences, Inc. | 2011 | — |
| +1 | K222143 | Apis (R), Veris (TM) | Sweetbio, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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…Common/Usual Name: Wound Dressing Classification Name: Dressing 4. PREDICATE DEVICES " Medihoney Primary Wound Dressings with Active Manuka Honey (K072956) * L-Mesitran® Dressing Family (K053613) 5. DEVICE DESCRIPTION Derma Sciences Medihoney Hydrogel Sheet Dressings with… | 2007 |
| * | K053613 | L-Mesitran Hydro, L-Mesitran Border, L-Mesitran Net, L-Mesitran ActiveSummary page 1…Classification Name: Dressing 4. PREDICATE DEVICES " Medihoney Primary Wound Dressings with Active Manuka Honey (K072956) * L-Mesitran® Dressing Family (K053613) 5. DEVICE DESCRIPTION Derma Sciences Medihoney Hydrogel Sheet Dressings with Leptospermum Honey are sterile, single-u… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222143 | Apis (R), Veris (TM) | 2023 | 0 |
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-2508-2025 | Under Investigation by firm | Packaging failures were identified which could lead to a breach in the sterile barrier. |
| Aug 5, 2025 | Class II | Z-2509-2025 | Under Investigation by firm | Packaging failures were identified which could lead to a breach in the sterile barrier. |
| Aug 5, 2025 | Class II | Z-2510-2025 | Under Investigation by firm | Packaging failures were identified which could lead to a breach in the sterile barrier. |
| Aug 5, 2025 | Class II | Z-2507-2025 | Under Investigation by firm | Packaging failures were identified which could lead to a breach in the sterile barrier. |
| Aug 5, 2025 | Class II | Z-2511-2025 | Under Investigation by firm | Packaging failures were identified which could lead to a breach in the sterile barrier. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 3 companies; a new generation was cleared every 20.1 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K222143 (Sweetbio, Inc., 2023) has gone furthest, with 0 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. 2011, 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 Hydrogel Sheet Dressings (Adhesive and Non-adhesive) with Leptospermum Honey provides a moist environment conducive to wound healing and are indicated for non-draining to lightly exuding wounds. For over the counter use, Medihoney Hydrogel Sheet Dressings (Adhesive and Non-adhesive) with Leptospermum Honey may be used for: minor abrasions minor cuts minor scalds Minor burns Under the supervision of a healthcare professional…
Read the full statement (139 words)
The Derma Sciences Medihoney Hydrogel Sheet Dressings (Adhesive and Non-adhesive) with Leptospermum Honey provides a moist environment conducive to wound healing and are indicated for non-draining to lightly exuding wounds.
For over the counter use, Medihoney Hydrogel Sheet Dressings (Adhesive and Non-adhesive) with Leptospermum Honey may be used for:
minor abrasions
minor cuts
minor scalds
Minor burns
Under the supervision of a healthcare professional, The Derma Sciences Medihoney Hydrogel Sheet Dressings provide a moist environment conducive to wound healing and are indicated for non-draining to lightly exuding wounds. The Medihoney Hydrogel Sheet 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, and traumatic and surgical wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110546 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110546: Medihoney Hydrogel Sheet Dressings with Active Leptospermum Honey.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110546
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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