510(k) · Cleared
Recalled · Class II · 2026Medihoney Gel Dressing 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 Feb 22, 2011 as substantially equivalent to K081584 (Derma Sciences, Inc., 2008) and 3 other predicates after a 239-day review. Its family tree reaches back 4 generations to 2007. 2 later devices descend from it. It has been recalled 4 times.
- Decided
- Feb 22, 2011
- Review
- 239 days
- Class
- Class U
- Product code
- FRO
- Recalls
- 4
- Predicates
- 4
Its longest line of descent runs back 4 generations to K053095 (2007). 13 ancestors in all, the oldest K935096 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK053095 Honey Alginate DressingDerma Sciences Canada, Inc. · 2007 · Recalled
- 3 generations backK072956 Medihoney Primary Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2007
- 2 generations backK080315 Derma Sciences Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008 · Recalled
- 1 generation backK081584 Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008
- This deviceK101793 Medihoney Gel Dressing with Active Manuka HoneyDerma Sciences, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK150676 L-Mesitran Dressing Family II- Soft and TulleTheo Manufacturing BV · 2015
- Descendant · cites it directly · 0 of its ownK150985 Medihoney Wound GelDerma Sciences, Inc. · 2015 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K053095 | Honey Alginate Dressing | Derma Sciences Canada, Inc. | 2007 | 1 |
| −3 | K072956 | Medihoney Primary Dressings with Active Manuka Honey | Derma Sciences, Inc. | 2007 | — |
| −2 | K080315 | Derma Sciences Medihoney Dressings with Active Manuka Honey | Derma Sciences, Inc. | 2008 | 3 |
| −1 | K081584 | Derma Sciences Otc Medihoney Dressings with Active Manuka Honey | Derma Sciences, Inc. | 2008 | — |
| 0 (this device) | K101793 | Medihoney Gel Dressing with Active Manuka Honey | Derma Sciences, Inc. | 2011 | — |
| +1 | K150676 | L-Mesitran Dressing Family II- Soft and Tulle | Theo Manufacturing BV | 2015 | — |
| +1 | K150985 | Medihoney Wound Gel | Derma Sciences, Inc. | 2015 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K081584 | Derma Sciences Otc Medihoney Dressings with Active Manuka HoneySummary page 1…e: Wound Dressing Classification Name: Dressing 3. PREDICATE DEVICES " Derma Sciences OTC Medihoney Dressings with Active Manuka Honey (1(081584) " Derma Sciences Medihoney Dressing with Active Manuka Honey (K0803 15) " Medihoney Primary Wound Dressings with Active Manu… | 2008 |
| * | K080315 | Derma Sciences Medihoney Dressings with Active Manuka HoneySummary page 1…ing 3. PREDICATE DEVICES " Derma Sciences OTC Medihoney Dressings with Active Manuka Honey (1(081584) " Derma Sciences Medihoney Dressing with Active Manuka Honey (K0803 15) " Medihoney Primary Wound Dressings with Active Manuka Honey (K07295,6) * API-MED Active Manuka Honey Wound Dressings (1(053… | 2008 |
| * | K072956 | Medihoney Primary Dressings with Active Manuka Honey | 2007 |
| * | K053095 | Honey Alginate DressingSummary page 1…Dressing with Active Manuka Honey (K0803 15) " Medihoney Primary Wound Dressings with Active Manuka Honey (K07295,6) * API-MED Active Manuka Honey Wound Dressings (1(053095) 4. DEVICE DESCRIPTION Derma Sciences Medihoney Gel Dressings with Active Manuka Honey are sterile, wound care dressings for… | 2007 |
What descends from it? (2)
2 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 |
|---|---|---|---|---|
| Jan 16, 2026 | Class II | Z-1363-2026 | Under Investigation by firm | Potential packaging failures, which could lead to a breach in the sterile barrier. |
| Jan 10, 2025 | Class II | Z-1168-2025 | Process control | Potential that the induction seal is not completely sealed to the device tube packaging. |
| May 25, 2022 | Class III | Z-1803-2022 | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage… |
| Mar 6, 2018 | Class II | Z-1630-2018 | Manufacturing material removal | Incorrect gel part number listed in a master manufacturing record |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 6 months on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K150676 (Theo Manufacturing BV, 2015) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K081584.
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 Gel Dressings with Active Manuka Honey provide a moist environment conducive to wound healing and are indicated for light to moderately exuding wounds. For over the counter use, Medihoney Gel Dressings with Active Manuka Honey may be used for: - minor abrasions - lacerations - minor cuts - minor scalds and burns Under the supervision of a healthcare professional, The Derma Sciences Medihoney Gel Dressings provide a moist…
Read the full statement (141 words)
The Derma Sciences Medihoney Gel Dressings with Active Manuka Honey provide a moist environment conducive to wound healing and are indicated for light to moderately exuding wounds.
For over the counter use, Medihoney Gel Dressings with Active Manuka Honey may be used for:
- minor abrasions
- lacerations
- minor cuts
- minor scalds and burns
Under the supervision of a healthcare professional, The Derma Sciences Medihoney Gel Dressings provide a moist environment conducive to wound healing and are indicated for light to moderate exuding wounds. The Medihoney Gel Wound 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 fill 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/K101793 · printed Nov 4, 2026
Cite this page
510(k) Report. “K101793: Medihoney Gel Dressing with Active Manuka Honey.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101793
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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