510(k) · Cleared

Cleared

Derma Sciences Otc Medihoney Dressings with Active Manuka Honey

K081584510(k) TraditionalCleared Jun 19, 200814-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 19, 2008 as substantially equivalent to K053095 (Derma Sciences Canada, Inc., 2007) and 6 other predicates after a 14-day review. Its family tree reaches back 3 generations to 2007. 14 later devices descend from it.

Decided: Jun 19, 2008
Review: 14 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 7

Its longest line of descent runs back 3 generations to K053095 (2007). 12 ancestors in all, the oldest K935096 (1994). 14 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 3 generations backK053095 Honey Alginate DressingDerma Sciences Canada, Inc. · 2007 · Recalled
2 generations backK072956 Medihoney Primary Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2007
1 generation backK080315 Derma Sciences Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008 · Recalled
This deviceK081584 Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008
Descendant · cites it directly · 10 of its ownK092689 Manukapli Wound DressingManuka Medical Limited · 2010
Descendant · 2 generations on · 4 of its ownK121227 Manuka FillLinks Medical Products, Inc. · 2012
Descendant · 3 generations on · 3 of its ownK131796 Manuka Fill Wound DressingLinks Medical Products, Inc. · 2014 · Recalled
Descendant · cites it directly · 3 of its ownK102659 Manukahd, Manukahd Rope, Manukahd BorderManuka Medical Limited · 2010
Descendant · 4 generations on · 2 of its ownK173911 Medline Burn and Wound DressingMedline Industries, Inc. · 2018

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2010high 3 (2011) · low 0 (2013)2026

Most influential descendants

Showing 5 of 14 · See all

K092689Manukapli Wound DressingManuka Medical Limited · 2010 · cites it directly10descendants
K121227Manuka FillLinks Medical Products, Inc. · 2012 · 2 generations on4descendants
K131796Manuka Fill Wound DressingLinks Medical Products, Inc. · 2014 · 3 generations on3descendants
K102659Manukahd, Manukahd Rope, Manukahd BorderManuka Medical Limited · 2010 · cites it directly3descendants
K173911Medline Burn and Wound DressingMedline Industries, Inc. · 2018 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K053095	Honey Alginate Dressing	Derma Sciences Canada, Inc.	2007	1
−2	K072956	Medihoney Primary Dressings with Active Manuka Honey	Derma Sciences, Inc.	2007	—
−1	K080315	Derma Sciences Medihoney Dressings with Active Manuka Honey	Derma Sciences, Inc.	2008	3
0 (this device)	K081584	Derma Sciences Otc Medihoney Dressings with Active Manuka Honey	Derma Sciences, Inc.	2008	—
+1	K092689	Manukapli Wound Dressing	Manuka Medical Limited	2010	—
+2	K121227	Manuka Fill	Links Medical Products, Inc.	2012	—
+3	K131796	Manuka Fill Wound Dressing	Links Medical Products, Inc.	2014	1
+1	K102659	Manukahd, Manukahd Rope, Manukahd Border	Manuka Medical Limited	2010	—
+4	K173911	Medline Burn and Wound Dressing	Medline Industries, Inc.	2018	—

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
2010	2	0
2011	3	0
2012	2	0
2014	2	0
2015	2	0
2018	1	0
2019	1	0
2026	1	0

FIG. 1 — Lineage of K081584, 2007–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (7)

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	Applicant	Decided	Recalls
*	K053095	Honey Alginate Dressing Summary page 1 …lassification Name: Dressing 3. PREDICATE DEVICES · API-MED Active Manuka Honey Wound Dressing that was cleared for marketing in the U.S. (K053095). (now called Medihoney) * Medihoney Primary Dressings with Active Manuka (Leptospermum) Honey in a hydrocolloi…	Derma Sciences Canada, Inc.	2007	1
*	K072956	Medihoney Primary Dressings with Active Manuka Honey Summary page 1 …in the U.S. (K053095). (now called Medihoney) * Medihoney Primary Dressings with Active Manuka (Leptospermum) Honey in a hydrocolloid sheet (K072956) * Medihoney Active Manuka (Leptospermum) 100% Honey dispensed from a tube 510(k) premarket notification (K0803…	Derma Sciences, Inc.	2007	—
*	K080315	Derma Sciences Medihoney Dressings with Active Manuka Honey Summary page 1 …ey in a hydrocolloid sheet (K072956) * Medihoney Active Manuka (Leptospermum) 100% Honey dispensed from a tube 510(k) premarket notification (K080315) · OTC Dermaphylyx Calcium Alginate Wound Dressings (K991608) * OTC CuraPharm Phytacare Sodium Alginate Wound Dre…	Derma Sciences, Inc.	2008	3
*	K991608	Dermaphylyx Calcium Alginate Wound Dressing Summary page 1 …tive Manuka (Leptospermum) 100% Honey dispensed from a tube 510(k) premarket notification (K080315) · OTC Dermaphylyx Calcium Alginate Wound Dressings (K991608) * OTC CuraPharm Phytacare Sodium Alginate Wound Dressing (K053538) · OTC NOCC Wound Gel Dressing cleared under K…	Dermaphylyx, Inc.	1999	—
*	K053538	Modification to Phytacare Alginate Hydrogel Wound Filler Summary page 1 …) premarket notification (K080315) · OTC Dermaphylyx Calcium Alginate Wound Dressings (K991608) * OTC CuraPharm Phytacare Sodium Alginate Wound Dressing (K053538) · OTC NOCC Wound Gel Dressing cleared under K080010 Derma Sciences 510(k) June 9, 2008 OTC Medih…	Curapharm, Inc.	2006	—
*	K080010	Nocc Hydrophilic Wound Dressing Summary page 1 …Calcium Alginate Wound Dressings (K991608) * OTC CuraPharm Phytacare Sodium Alginate Wound Dressing (K053538) · OTC NOCC Wound Gel Dressing cleared under K080010 Derma Sciences 510(k) June 9, 2008 OTC Medihoney Dressings with Active Manuka Honey Append…	Kytogenics, Inc.	2008	—
*	K013814	Absorbent Antimicrobial Wound Dressing Summary page 2 …08 OTC Medihoney Dressings with Active Manuka Honey Appendix C - Page 1 of 3 · OTC and Rx Aquacel Ag Wound dressing cleared under K013814. 4. DEVICE DESCRIPTION The Derma Sciences OTC Medihoney Dressings (APIMED, Medihoney Primary and Medihoney 100% Gel)…	Convatec, A Division of E.R. Squibb & Sons	2002	—

Also cleared against K053095: 4 other devices →

What descends from it? (14)

See all 14

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K092689	Manukapli Wound Dressing	Manuka Medical Limited	2010	10
K102659	Manukahd, Manukahd Rope, Manukahd Border	Manuka Medical Limited	2010	3
K101793	Medihoney Gel Dressing with Active Manuka Honey	Derma Sciences, Inc.	2011	2
K101114	Advancis Activon Tube	Advancis Medical	2011	0

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 1 year and passes through 2 companies; a new generation was cleared every 4 months on median.
2 of the 12 ancestors have a recall of any class.
Of its descendants, K092689 (Manuka Medical Limited, 2010) has gone furthest, with 10 descendants of its own.
4 other devices also cite its predicate K053095.

How does its category compare?

All FRO devices

FRO 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

2007high 31 (2009) · low 8 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRO

176in 2025

2007high 332 (2022) · low 96 (2012)2026

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

Recalls per year · FRO

2in 2024

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

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

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?

For over the counter use, MEDIHONEY T M APIMED, PRIMARY and 100% HONEY 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 Apimed (MediHoney) Dressings are all indicated for moderate to heavily exuding wounds. The Medihoney Primary-Wound Dressings are indicated for lightly to moderately exuding wounds. The Medihoney…

Read the full statement (139 words)

For over the counter use, MEDIHONEY T M APIMED, PRIMARY and 100% HONEY 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 Apimed (MediHoney) Dressings are all indicated for moderate to heavily exuding wounds. The Medihoney Primary-Wound Dressings are indicated for lightly to moderately exuding wounds. The Medihoney 100% Honey Dressings are indicated for non-exuding to moderately exuding wounds. All of the Medihoney 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 and traumatic and surgical wounds.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081584 · printed Nov 6, 2026

Cite this page

510(k) Report. “K081584: Derma Sciences Otc 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/K081584

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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