510(k) Report

510(k) · Cleared

Cleared

Coreleader Colla-Algi Fiber Model Caw

K111578510(k) TraditionalCleared Sep 23, 2011108-day reviewClass U

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

Coreleader Biotech Co., Ltd. · FRO Dressing, Wound, Drug

Cleared on Sep 23, 2011 as substantially equivalent to K925548 (Johnson & Johnson Medical, Inc., 1993) and 3 other predicates after a 108-day review. Its family tree reaches back 2 generations to 1988.

Decided
Sep 23, 2011
Review
108 days
Class
Class U
Product code
FRO
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K881854 (1988). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1993: 1 other ancestor1992: 1 other ancestor1991: 2 other ancestorsK881854 · Sorbsan Topical Wound Dressing · E.G. Dick & Assoc. · 1988K982597 · Fibrcol Plus Collagen Wound Dressing with Alginate · Johnson & Johnson Medical, Inc. · 1998198519901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor K982597 · Fibrcol Plus Collagen Wound Dressing with Alginate · Johnson & Johnson Medical, Inc. · 1998K881854 · Sorbsan Topical Wound Dressing · E.G. Dick & Assoc. · 19880
  1. Root · 2 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
  2. 1 generation backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
  3. This deviceK111578 Coreleader Colla-Algi Fiber Model CawCoreleader Biotech Co., Ltd. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K881854Sorbsan Topical Wound DressingE.G. Dick & Assoc.1988—
−1K982597Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc.1998—
0 (this device)K111578Coreleader Colla-Algi Fiber Model CawCoreleader Biotech Co., Ltd.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199120
199210
199310
FIG. 1 — Lineage of K111578, 1988–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K925548Fibracol Collagen-Alginate Dressing
Summary page 1
…der Colla-Algi Fiber Dressing is substantially equivalent to. FIBRACOL COLLAGEN-ALGINATE DRESSING (K(925548). Manufactured by JOHNSON & JOHNSON MEDICAL, INC. FIBRCOL PLUS COLLAGEN WOUND DRESS…
Johnson & Johnson Medical, Inc.1993—
*K982597Fibrcol Plus Collagen Wound Dressing with Alginate
Summary page 1
…anufactured by JOHNSON & JOHNSON MEDICAL, INC. FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATE (K(982597). Manufactured by JOHNSON & JOHNSON MEDICAL, INC. KALLTOSTAT FORTEX WOUND DRESSING…
Johnson & Johnson Medical, Inc.1998—
*K921009Kaltostat Fortex Wound Dressing
Summary page 1
…GINATE (K(982597). Manufactured by JOHNSON & JOHNSON MEDICAL, INC. KALLTOSTAT FORTEX WOUND DRESSING (K921009). Manufactured by CALGON VESTAL DIV KALTOSTAT WOUND DRESSING (K(910059). Manufactur…
Calgon Vestal Div.1992—
*K910059Kaltostat Wound Dressing
Summary page 1
…KALLTOSTAT FORTEX WOUND DRESSING (K921009). Manufactured by CALGON VESTAL DIV KALTOSTAT WOUND DRESSING (K(910059). Manufactured by CALGON VESTAL DIV Device Description: Coreleader Colla-Alig Fiber Dressing with Alg…
Calgon Vestal Div.1991—

Also cleared against K925548: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 23 years and passes through 3 companies; a new generation was cleared every 13.1 years on median.
  • None of the 6 ancestors has a recall.
  • 3 other devices also cite its predicate K925548.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?

Coreleader Colla-Algi Fiber Dressing is indicated for management of exuding wounds including:

Full-thickness and partial-thickness wounds

Pressure ulcers

Venous ulcers

Ulcers caused by mixed vascular etiologies

Diabetic ulcers

Second-degree burns

Donor sites and other bleeding surface wounds

Abrasions

Traumatic wounds healing by secondary intention

Dehisced surgical incisions

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K925548

3 other devices cite the same predicate.

  • K040314HealicollEncoll Corp. · 2004
  • K030921Collagen Topical Wound DressingCollagen Matrix, Inc. · 2003
  • K982597Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998

More from Coreleader Biotech Co., Ltd.

9 FDA decisions under this applicant name. See the company

  • K151204HEMO-BandageCoreleader Biotech Co., Ltd. · 2015
  • K141382Bios King Biocellulose FilmCoreleader Biotech Co., Ltd. · 2015
  • K123394Coreleader Hydro-Healer Hydrocolloid Wound DressingCoreleader Biotech Co., Ltd. · 2013
  • K111733Coreleader Scar-DimmerCoreleader Biotech Co., Ltd. · 2011
  • K102944Coreleader Hemo-Pad Model Cpii 02030Coreleader Biotech Co., Ltd. · 2011

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/K111578 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111578: Coreleader Colla-Algi Fiber Model Caw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111578

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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