510(k) · Cleared
Recalled · Class II · 2026Medihoney Wound Gel
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 Nov 19, 2015 as substantially equivalent to K101793 (Derma Sciences, Inc., 2011) and 1 other predicate after a 219-day review. Its family tree reaches back 6 generations to 1992. It has been recalled once.
- Decided
- Nov 19, 2015
- Review
- 219 days
- Class
- Class U
- Product code
- FRO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K914579 (1992). 33 ancestors in all, the oldest K890354 (1989). No later device cites it as a predicate yet.
- Root · 6 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 5 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 4 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 3 generations backK023609 Silverlon Adhesive StripArgentum International, LLC · 2003
- 2 generations backK082333 Asap Wound Dressing GelAmerican Biotech Labs · 2009
- 1 generation backK131176 Ross RU Skin DiscontinuitiesBiotd S.A. · 2014
- This deviceK150985 Medihoney Wound GelDerma Sciences, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −5 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −4 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −3 | K023609 | Silverlon Adhesive Strip | Argentum International, LLC | 2003 | — |
| −2 | K082333 | Asap Wound Dressing Gel | American Biotech Labs | 2009 | — |
| −1 | K131176 | Ross RU Skin Discontinuities | Biotd S.A. | 2014 | — |
| 0 (this device) | K150985 | Medihoney Wound Gel | Derma Sciences, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K101793 | Medihoney Gel Dressing with Active Manuka HoneySummary page 4…The Derma Sciences Medihoney Wound Gel is substantially equivalent in design, function and intended use to the original Medihoney Gel Dressings With Active Manuka (K 101793) and the BioTD S.A. Ross Ru Skin Discontinuities (K131176). 4. DEVICE DESCRIPTION The primary component of the Medihone… | 2011 |
| * | K131176 | Ross RU Skin DiscontinuitiesSummary page 4…ivalent in design, function and intended use to the original Medihoney Gel Dressings With Active Manuka (K 101793) and the BioTD S.A. Ross Ru Skin Discontinuities (K131176). 4. DEVICE DESCRIPTION The primary component of the Medihoney Wound Gel is Active Leptospermum Honey. The purpose of t… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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-1365-2026 | Under Investigation by firm | Potential packaging failures, 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 23 years and passes through 6 companies; a new generation was cleared every 4.3 years on median.
- 4 of the 33 ancestors have a recall of any class.
- 1 other device also cites its predicate K101793.
How does its category compare?
All FRO devicesFRO 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
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?
Derma Sciences Medihoney Wound Gel helps maintain moist environment. Moist wound environment was shown to be conducive to wound healing. For over the counter use, Medihoney Wound Gel with Active Leptospermum Honey may be used for: -minor abrasions -lacerations -minor cuts -minor scalds and burns Under the supervision of a healthcare professional, Medihoney Wound Gel helps maintain a moist environment. Moist wound environment was shown to be conducive to…
Read the full statement (131 words)
Derma Sciences Medihoney Wound Gel helps maintain moist environment. Moist wound environment was shown to be conducive to wound healing.
For over the counter use, Medihoney Wound Gel with Active Leptospermum Honey may be used for:
-minor abrasions
-lacerations
-minor cuts
-minor scalds and burns
Under the supervision of a healthcare professional, Medihoney Wound Gel helps maintain a moist environment. Moist wound environment was shown to be conducive to wound healing and are indicated for non-draining to moderately 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 full thickness) '
-1st and 2nd degree partial thickness burns
-donor sites, traumatic and surgical wounds
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150985 · printed Nov 3, 2026
Cite this page
510(k) Report. “K150985: Medihoney Wound Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K150985
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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