510(k) Report

510(k) · Cleared

Cleared

Modification to Phytacare Alginate Hydrogel Wound Filler

K053538510(k) TraditionalCleared Oct 10, 2006294-day reviewClass U

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

Curapharm, Inc. · FRO Dressing, Wound, Drug

Cleared on Oct 10, 2006 as substantially equivalent to K962218 (Carrington Laboratories, Inc., 1996) and 3 other predicates after a 294-day review. Its family tree reaches back 1 generation to 1994. 15 later devices descend from it.

Decided
Oct 10, 2006
Review
294 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K935096 (1994). 4 ancestors in all. 15 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1996: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor2008: 1 descendant cleared2010: 2 descendants cleared2011: 3 descendants cleared2012: 2 descendants cleared2015: 2 descendants cleared2014: 2 descendants cleared2018: 1 descendant cleared2026: 1 descendant cleared2019: 1 descendant clearedK935096 · Biolex Impregnated Wound Dressing · C.R. Bard, Inc. · 19941990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 4 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants5 generations forward: 2 descendants6 generations forward: 2 descendants K935096 · Biolex Impregnated Wound Dressing · C.R. Bard, Inc. · 19940+5
  1. Root · 1 generation backK935096 Biolex Impregnated Wound DressingC.R. Bard, Inc. · 1994
  2. This deviceK053538 Modification to Phytacare Alginate Hydrogel Wound FillerCurapharm, Inc. · 2006
  3. Descendant · cites it directly · 14 of its ownK081584 Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008
  4. Descendant · 2 generations on · 10 of its ownK092689 Manukapli Wound DressingManuka Medical Limited · 2010
  5. Descendant · 3 generations on · 4 of its ownK121227 Manuka FillLinks Medical Products, Inc. · 2012
  6. Descendant · 4 generations on · 3 of its ownK131796 Manuka Fill Wound DressingLinks Medical Products, Inc. · 2014 · Recalled
  7. Descendant · 2 generations on · 3 of its ownK102659 Manukahd, Manukahd Rope, Manukahd BorderManuka Medical Limited · 2010

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2008: 12010: 22011: 32012: 22014: 22015: 22018: 12019: 12026: 1
2008high 3 (2011) · low 0 (2009)2026

Most influential descendants

Showing 5 of 15 · See all
  • K081584Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008 · cites it directly14descendants
  • K092689Manukapli Wound DressingManuka Medical Limited · 2010 · 2 generations on10descendants
  • K121227Manuka FillLinks Medical Products, Inc. · 2012 · 3 generations on4descendants
  • K131796Manuka Fill Wound DressingLinks Medical Products, Inc. · 2014 · 4 generations on3descendants
  • K102659Manukahd, Manukahd Rope, Manukahd BorderManuka Medical Limited · 2010 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K935096Biolex Impregnated Wound DressingC.R. Bard, Inc.1994—
0 (this device)K053538Modification to Phytacare Alginate Hydrogel Wound FillerCurapharm, Inc.2006—
+1K081584Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc.2008—
+2K092689Manukapli Wound DressingManuka Medical Limited2010—
+3K121227Manuka FillLinks Medical Products, Inc.2012—
+4K131796Manuka Fill Wound DressingLinks Medical Products, Inc.20141
+2K102659Manukahd, Manukahd Rope, Manukahd BorderManuka Medical Limited2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201020
201130
201220
201420
201520
201810
201910
202610
FIG. 1 — Lineage of K053538, 1994–2026Source: 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 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. #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? (6)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K962218Carrasyn Hydrogel Wound Dressing,Carragauze Pads,Carragauze Strips,Carrasorb M FDG
Summary page 1
…which Substantial Equivalence is Claimed: The Phytacare® Alginate Hydrogel, Wound Dressing is substantially equivalent to one or more of the following devices. 1. K962218 - CarraGauze® Carrasyn Hydrogel, Wound Dressing, Carrington Laboratories 2. K53450 - Curasol® Gel, Wound Dressing, H…
Carrington Laboratories, Inc.1996—
Kept off the family treeK053450FDA’s K053450 is Atlantis Abutment for Zimmer Interface
Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
Atlantis Components, Inc.2006—
*K935096Biolex Impregnated Wound Dressing
Summary page 1
…aboratories 2. K53450 - Curasol® Gel, Wound Dressing, Healthpoint Medical 3. Unknown - TransiGel® Conformable Gel Dressing, Smith & Nephew United, Inc. 4. K935096 - Biolex Impregnated Wound Dressing, C.R. Bard, Inc. 5. K954738 - DermaGran® Hydrophyllic Wound Dressing, Derma Sciences 6.…
C.R. Bard, Inc.1994—
*K954738Dermagran Hydrophilic Wound Dressing
Summary page 1
…t Medical 3. Unknown - TransiGel® Conformable Gel Dressing, Smith & Nephew United, Inc. 4. K935096 - Biolex Impregnated Wound Dressing, C.R. Bard, Inc. 5. K954738 - DermaGran® Hydrophyllic Wound Dressing, Derma Sciences 6. K942270 - Saf-Gel, Hydrating Dermal Wound Dressing with Alginate…
Derma Sciences, Inc.1995—
*K942270Saf-Gel Hydrating Dermal Wound Dressing
Summary page 1
…Nephew United, Inc. 4. K935096 - Biolex Impregnated Wound Dressing, C.R. Bard, Inc. 5. K954738 - DermaGran® Hydrophyllic Wound Dressing, Derma Sciences 6. K942270 - Saf-Gel, Hydrating Dermal Wound Dressing with Alginate ConvaTec 7. K053538 - Phytacare® Alginate Hydrogel Wound Dr…
Calgon Vestal Div.1994—
*—TransiGel® Conformable Gel Dressing
Named without a submission number
—

Also cleared against K962218: 2 other devices →

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K081584Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc.200814

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?

  • None of the 4 ancestors has a recall.
  • Of its descendants, K081584 (Derma Sciences, Inc., 2008) has gone furthest, with 14 descendants of its own.
  • 2 other devices also cite its predicate K962218.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

The Phytacare Alginate Hydrogel Wound Dressing is indicated for use in the management of 1st and 2 nd degree burns, minor cuts and abrasions.

Under the care of a healthcare professional the Phytacare Alginate Hydrogel Wound Dressing is indicated for use in the management of diabetic ulcers, foot ulcers, 1st and 2 nd degree burns, pressure ulcers (stages I-IV), cuts and abrasions.

Indications for use as stated in the FDA summary.

Also cleared against K962218

2 other devices cite the same predicate.

  • K130781L.a.M. Ipm Wound Gel, Ipm Derm GelGlycobiosciences, Inc. · 2014
  • K981150Solosite Gel Conformable DressingSmith & Nephew, Inc. · 1998

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/K053538 · printed Nov 5, 2026

Cite this page

510(k) Report. “K053538: Modification to Phytacare Alginate Hydrogel Wound Filler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053538

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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