510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Honey Alginate Dressing

K053095510(k) TraditionalCleared Jul 12, 2007616-day reviewClass URecalls 1

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

Derma Sciences Canada, Inc. · FRO Dressing, Wound, Drug

Cleared on Jul 12, 2007 after a 616-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 24 later devices descend from it. It has been recalled once.

Decided
Jul 12, 2007
Review
616 days
Class
Class U
Product code
FRO
Recalls
1
Predicates
0

24 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2008: 2 descendants cleared2011: 4 descendants cleared2010: 3 descendants cleared2009: 1 descendant cleared2015: 3 descendants cleared2019: 2 descendants cleared2012: 2 descendants cleared2023: 1 descendant cleared2014: 2 descendants cleared2021: 1 descendant cleared2018: 1 descendant cleared2026: 1 descendant cleared20052010201520202025
  1. This deviceK053095 Honey Alginate DressingDerma Sciences Canada, Inc. · 2007
  2. Descendant · cites it directly · 23 of its ownK072956 Medihoney Primary Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2007
  3. Descendant · cites it directly · 16 of its ownK080315 Derma Sciences Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008 · Recalled
  4. Descendant · cites it directly · 14 of its ownK081584 Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008
  5. Descendant · 2 generations on · 10 of its ownK092689 Manukapli Wound DressingManuka Medical Limited · 2010
  6. Descendant · 2 generations on · 5 of its ownK083334 Elasto-Gel Manuka Honey Wound DressingSouthwest Technologies, Inc. · 2009

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22009: 12010: 32011: 42012: 22014: 22015: 32018: 12019: 22021: 12023: 12026: 1
2007high 4 (2011) · low 0 (2013)2026

Most influential descendants

Showing 5 of 24 · See all
  • K072956Medihoney Primary Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2007 · cites it directly23descendants
  • 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 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K053095Honey Alginate DressingDerma Sciences Canada, Inc.2007—
+1K072956Medihoney Primary Dressings with Active Manuka HoneyDerma Sciences, Inc.2007—
+1K080315Derma Sciences Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc.20083
+1K081584Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc.2008—
+2K092689Manukapli Wound DressingManuka Medical Limited2010—
+2K083334Elasto-Gel Manuka Honey Wound DressingSouthwest Technologies, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
200910
201030
201140
201220
201420
201530
201810
201920
202110
202310
202610
FIG. 1 — Lineage of K053095, 2007–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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. #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (24)

See all 24

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

NumberDeviceApplicantDecidedDescendants
K072956Medihoney Primary Dressings with Active Manuka HoneyDerma Sciences, Inc.200723
K080315Derma Sciences Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc.200816
K081584Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc.200814
K101793Medihoney Gel Dressing with Active Manuka HoneyDerma Sciences, Inc.20112
K102478Otc Elasto-Gel Manuka Honey Wound DressingSouthwest Technologies, Inc.20101

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 16, 2026Class IIZ-1364-2026Under Investigation by firmPotential 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?

  • Of its descendants, K072956 (Derma Sciences, Inc., 2007) has gone furthest, with 23 descendants of its own.

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

2007: 292008: 262009: 312010: 312011: 272012: 242013: 192014: 222015: 282016: 282017: 232018: 202019: 162020: 122021: 82022: 92023: 182024: 242025: 112026 (partial year): 17
2007high 31 (2009) · low 8 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRO

176in 2025

2007: 187 days median2008: 130 days median2009: 136 days median2010: 146 days median2011: 177 days median2012: 96 days median2013: 194 days median2014: 214 days median2015: 249 days median2016: 222 days median2017: 147 days median2018: 206 days median2019: 270 days median2020: 226 days median2021: 275 days median2022: 332 days median2023: 283 days median2024: 263 days median2025: 176 days median2026 (partial year): 254 days median
2007high 332 (2022) · low 96 (2012)2026

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

Recalls per year · FRO

2in 2024

2007: 42008: 12009: 12011: 42013: 12014: 12015: 22016: 32017: 12019: 12021: 62022: 22023: 2, 2 Class I2024: 22026 (partial year): 2
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

2007: 552008: 302009: 452010: 1222011: 422012: 652013: 1392014: 2692015: 2972016: 1472017: 1492018: 1282019: 1362020: 1392021: 1832022: 1762023: 1982024: 2322025: 192
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200729187455
200826130130
200931136145
2010311460122
201127177442
20122496065
2013191941139
2014222141269
2015282492297
2016282223147
2017231471149
2018202060128
2019162701136
2020122260139
202182756183
202293322176
2023182832 (2)198
2024242632232
2025111760192
2026172542—

What is it indicated for?

Under the supervision of a healthcare professional, API-MED ACTIVE MANUKA HONEY ABSORBENT Dressing provides a moist environment conducive to wound healing and is indicated for moderate to heavily 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 510(k) statement.

More from Derma Sciences Canada, Inc.

3 FDA decisions under this applicant name. See the company

  • K080497Derma Sciences Calcium Alginate Dressing with Antimicrobial Silver (Algicell AG)Derma Sciences Canada, Inc. · 20081 recall
  • K052536Algicell AGDerma Sciences Canada, Inc. · 2006

Recent decisions in FRO

The FRO category page

  • K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH · 2026
  • K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC · 2026
  • K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd. · 2026
  • K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC · 2026
  • K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc. · 2026

https://510kreport.com/device/K053095 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053095: Honey Alginate Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053095

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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