510(k) · Cleared

Cleared

Medihoney Primary Dressings with Active Manuka Honey

K072956510(k) TraditionalCleared Nov 7, 200719-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 Nov 7, 2007 as substantially equivalent to K053095 (Derma Sciences Canada, Inc., 2007) after a 19-day review. Its family tree reaches back 1 generation to 2007. 23 later devices descend from it.

Decided: Nov 7, 2007
Review: 19 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K053095 (2007). 23 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK053095 Honey Alginate DressingDerma Sciences Canada, Inc. · 2007 · Recalled
This deviceK072956 Medihoney Primary Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2007
Descendant · cites it directly · 16 of its ownK080315 Derma Sciences Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008 · Recalled
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 · cites it directly · 5 of its ownK083334 Elasto-Gel Manuka Honey Wound DressingSouthwest Technologies, Inc. · 2009
Descendant · 3 generations on · 4 of its ownK121227 Manuka FillLinks Medical Products, Inc. · 2012

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2008high 4 (2011) · low 0 (2013)2026

Most influential descendants

Showing 5 of 23 · See all

K080315Derma Sciences Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008 · cites it directly16descendants
K081584Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008 · cites it directly14descendants
K092689Manukapli Wound DressingManuka Medical Limited · 2010 · 2 generations on10descendants
K083334Elasto-Gel Manuka Honey Wound DressingSouthwest Technologies, Inc. · 2009 · cites it directly5descendants
K121227Manuka FillLinks Medical Products, Inc. · 2012 · 3 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K053095	Honey Alginate Dressing	Derma Sciences Canada, Inc.	2007	1
0 (this device)	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
+1	K081584	Derma Sciences Otc Medihoney Dressings with Active Manuka Honey	Derma Sciences, Inc.	2008	—
+2	K092689	Manukapli Wound Dressing	Manuka Medical Limited	2010	—
+1	K083334	Elasto-Gel Manuka Honey Wound Dressing	Southwest Technologies, Inc.	2009	—
+3	K121227	Manuka Fill	Links Medical Products, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	2	0
2009	1	0
2010	3	0
2011	4	0
2012	2	0
2014	2	0
2015	3	0
2018	1	0
2019	2	0
2021	1	0
2023	1	0
2026	1	0

FIG. 1 — Lineage of K072956, 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

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What was it cleared against? (1)

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 …Common/Usual Name: Wound Dressing Classification Name: Dressing 3. PREDICATE DEVICES API-MED Active Manuka Honey Wound Dressings (K053095) 4. DEVICE DESCRIPTION Derma Sciences Medihoney Primary Dressings with Active Manuka Honey are sterile, single-use wound…	Derma Sciences Canada, Inc.	2007	1

Also cleared against K053095: 4 other devices →

What descends from it? (23)

See all 23

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

Number	Device	Applicant	Decided	Descendants
K080315	Derma Sciences Medihoney Dressings with Active Manuka Honey	Derma Sciences, Inc.	2008	16
K081584	Derma Sciences Otc Medihoney Dressings with Active Manuka Honey	Derma Sciences, Inc.	2008	14
K083334	Elasto-Gel Manuka Honey Wound Dressing	Southwest Technologies, Inc.	2009	5
K101793	Medihoney Gel Dressing with Active Manuka Honey	Derma Sciences, Inc.	2011	2
K110546	Medihoney Hydrogel Sheet Dressings with Active Leptospermum Honey	Derma Sciences, Inc.	2011	1
K102478	Otc Elasto-Gel Manuka Honey Wound Dressing	Southwest Technologies, Inc.	2010	1

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?

Its one ancestor has a recall.
Of its descendants, K080315 (Derma Sciences, Inc., 2008) has gone furthest, with 16 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. 2007, 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?

The Derma Sciences Medihoney Primary Dressing with Active Manuka Honey provides a moist environment conducive to wound healing and is indicated for 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/K072956 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072956: Medihoney Primary 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/K072956

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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