510(k) Report

510(k) · Cleared

Cleared

Puracol Plus AG Collagen Microscaffold Wound Dressing

K071552510(k) AbbreviatedCleared Apr 25, 2008324-day reviewClass U

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

Medline Industries, Inc. · FRO Dressing, Wound, Drug

Cleared on Apr 25, 2008 after a 324-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 11 later devices descend from it.

Decided
Apr 25, 2008
Review
324 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
0

11 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2016: 1 descendant cleared2024: 4 descendants cleared2013: 1 descendant cleared2022: 2 descendants cleared2023: 2 descendants cleared20052010201520202025
  1. This deviceK071552 Puracol Plus AG Collagen Microscaffold Wound DressingMedline Industries, Inc. · 2008
  2. Descendant · cites it directly · 5 of its ownK112191 Healex Biosponge Wound DressingBionova Medical, Inc. · 2012
  3. Descendant · cites it directly · 4 of its ownK123961 Sentrex Biosponge MPDBionova Medical, Inc. · 2013
  4. Descendant · 2 generations on · 3 of its ownK210949 Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2022
  5. Descendant · cites it directly · 3 of its ownK161067 Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound…Engineered Tissue Solutions, LLC · 2016
  6. Descendant · 3 generations on · 2 of its ownK231937 Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2023

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2012: 12013: 12016: 12022: 22023: 22024: 4
2012high 4 (2024) · low 0 (2014)2026

Most influential descendants

Showing 5 of 11 · See all
  • K112191Healex Biosponge Wound DressingBionova Medical, Inc. · 2012 · cites it directly5descendants
  • K123961Sentrex Biosponge MPDBionova Medical, Inc. · 2013 · cites it directly4descendants
  • K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2022 · 2 generations on3descendants
  • K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC · 2016 · cites it directly3descendants
  • K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2023 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K071552Puracol Plus AG Collagen Microscaffold Wound DressingMedline Industries, Inc.2008—
+1K112191Healex Biosponge Wound DressingBionova Medical, Inc.2012—
+1K123961Sentrex Biosponge MPDBionova Medical, Inc.2013—
+2K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.2022—
+1K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”…Engineered Tissue Solutions, LLC2016—
+3K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201310
201610
202220
202320
202440
FIG. 1 — Lineage of K071552, 2008–2024Source: 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? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K112191Healex Biosponge Wound DressingBionova Medical, Inc.20125
K123961Sentrex Biosponge MPDBionova Medical, Inc.20134
K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC20163
K240809LUOFUCON® Silver Collagen DressingHuizhou Foryou Medical Devices Co., Ltd.20240

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?

  • Of its descendants, K112191 (Bionova Medical, Inc., 2012) has gone furthest, with 5 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. 2008, 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?

Puracol® Plus Ag MicroScaffold TM Wound Dressing is indicated for the management of:

Full thickness and partial thickness wounds

Pressure ulcers

Venous ulcers

Ulcers caused by mixed vascular etiologies

Diabetic ulcers

First and second degree bums

Donor sites and other bleeding surface wounds

Abrasions

Trauma wounds healing by secondary intention

Dehisced wounds

Surgical wounds

Dehisced surgical wounds

These dressings may be cut to size and may be layered for the management of deep wounds.

Indications for use as stated in the FDA 510(k) statement.

More from Medline Industries, Inc.

238 FDA decisions under this applicant name. See the company

  • DEN210049Medline ART Skin Harvesting SystemMedline Industries, Inc. · 2024
  • K230559Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier…Medline Industries, Inc. · 2023
  • K223100Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)Medline Industries, Inc. · 2023
  • K222665Medline UNITE® Ankle Fusion Plating SystemMedline Industries, Inc. · 2023
  • K213054Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety SyringeMedline Industries, Inc. · 2022

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/K071552 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071552: Puracol Plus AG Collagen Microscaffold Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071552

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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