510(k) · Cleared

Cleared

Otc Elasto-Gel Manuka Honey Wound Dressing

K102478510(k) TraditionalCleared Nov 3, 201065-day reviewClass U

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Southwest Technologies, Inc. · FRO Dressing, Wound, Drug

Cleared on Nov 3, 2010 as substantially equivalent to K872165 (Southwest Technologies, Inc., 1987) and 3 other predicates after a 65-day review. Its family tree reaches back 3 generations to 2007. 1 later device descends from it.

Decided: Nov 3, 2010
Review: 65 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K053095 (2007). 4 ancestors in all, the oldest K872165 (1987). 1 later device descends from it, 1 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 backK083334 Elasto-Gel Manuka Honey Wound DressingSouthwest Technologies, Inc. · 2009
This deviceK102478 Otc Elasto-Gel Manuka Honey Wound DressingSouthwest Technologies, Inc. · 2010
Descendant · cites it directly · 0 of its ownK101114 Advancis Activon TubeAdvancis Medical · 2011

Most influential descendants

Showing 1 of 1 · See all

K101114Advancis Activon TubeAdvancis Medical · 2011 · cites it directly0descendants

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	K083334	Elasto-Gel Manuka Honey Wound Dressing	Southwest Technologies, Inc.	2009	—
0 (this device)	K102478	Otc Elasto-Gel Manuka Honey Wound Dressing	Southwest Technologies, Inc.	2010	—
+1	K101114	Advancis Activon Tube	Advancis Medical	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0

FIG. 1 — Lineage of K102478, 2007–2011Source: 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? (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	Applicant	Decided	Recalls
*	K872165	Elasto-Gel Occlusive Dressing Summary page 1 …quivalence Claim- Predicate Devices Legally marketed devices: E~lasto-Gel Occlusive Dressing by Southwest Technologies (1K872165) Elasto-gel Manuka Honey Wound Dressings (K(083334) Derma Sciences APIMED Tm Ac…	Southwest Technologies, Inc.	1987	2
*	K083334	Elasto-Gel Manuka Honey Wound Dressing Summary page 1 …devices: E~lasto-Gel Occlusive Dressing by Southwest Technologies (1K872165) Elasto-gel Manuka Honey Wound Dressings (K(083334) Derma Sciences APIMED Tm Active Manuka Honey Absorbent Dressing by Derma Sciences…	Southwest Technologies, Inc.	2009	—
*	K053095	Honey Alginate Dressing Summary page 1 …sings (K(083334) Derma Sciences APIMED Tm Active Manuka Honey Absorbent Dressing by Derma Sciences Canada, hi (K053095) Product Code FRO Derma Sciences Medilioncy Priniary Dressings with Active Manuka Honey by Dernia Scienc…	Derma Sciences Canada, Inc.	2007	1
*	K072956	Medihoney Primary Dressings with Active Manuka Honey Summary page 1 …Product Code FRO Derma Sciences Medilioncy Priniary Dressings with Active Manuka Honey by Dernia Sciences (1K072956) 4. Device Description OTC Elasto-Gel Manuka dressings are supplied as~a gel (amorp…	Derma Sciences, Inc.	2007	—

Also cleared against K872165: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
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 3 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
2 of the 4 ancestors have a recall of any class.
Of its descendants, K101114 (Advancis Medical, 2011) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K872165.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 OTC Manuka Honey Wound Dressing is indicated far minor cuts, minor abrasions, minor scalds and minor burns.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102478 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102478: Otc Elasto-Gel Manuka Honey Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102478

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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