510(k) · Cleared

Cleared

Coreleader Algi-Fiber Wound Dressing Model Adw 05050

K102943510(k) TraditionalCleared Apr 12, 2011190-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 Apr 12, 2011 as substantially equivalent to K910059 (Calgon Vestal Div., 1991) and 1 other predicate after a 190-day review. Its family tree reaches back 2 generations to 1995.

Decided: Apr 12, 2011
Review: 190 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K953497 (1995). 3 ancestors in all, the oldest K910059 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK953497 Comfeel:Alginate DressingColoplast A/S · 1995
1 generation backK983519 Comfeel Seasorb DressingColoplast Corp. · 1998 · Recalled
This deviceK102943 Coreleader Algi-Fiber Wound Dressing Model Adw 05050Coreleader Biotech Co., Ltd. · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K953497	Comfeel:Alginate Dressing	Coloplast A/S	1995	—
−1	K983519	Comfeel Seasorb Dressing	Coloplast Corp.	1998	1
0 (this device)	K102943	Coreleader Algi-Fiber Wound Dressing Model Adw 05050	Coreleader Biotech Co., Ltd.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0

FIG. 1 — Lineage of K102943, 1995–2011Source: 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? (2)

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
*	K910059	Kaltostat Wound Dressing Summary page 1 …mmon Name: Topical Wound Dressing Classification: Unclassified Classification Hydrophilic Wound and Burn Dressing Name: Predicate CALGON VESTAL DIV, K910059, KALTOSTAT WOUND Device: DRESSING COLOPLAST CORP., K9835 19, COMFEEL SEASORB DRESSI…	Calgon Vestal Div.	1991	—
*	K983519	Comfeel Seasorb Dressing Summary page 1 …Hydrophilic Wound and Burn Dressing Name: Predicate CALGON VESTAL DIV, K910059, KALTOSTAT WOUND Device: DRESSING COLOPLAST CORP., K9835 19, COMFEEL SEASORB DRESSING COMFEEL SEASORE CORELEADER…	Coloplast Corp.	1998	1

Also cleared against K910059: 2 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 16 years and passes through 3 companies; a new generation was cleared every 12.3 years on median.
1 of the 3 ancestors has a recall of any class.
2 other devices also cite its predicate K910059.

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

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 following indications for use of the product should be managed under the supervision of a health care professional: Coreleader Algi-Fiber wound dressing is indicated as a primary dressing for the management of moderate to heavily exuding wounds, partial and full thickness wounds including chronic wounds such as leg ulcers, pressure sores and acute wounds such as donor sites, abrasions, lacerations and post-surgical wounds. The following conditions…

Read the full statement (104 words)

The following indications for use of the product should be managed under the supervision of a health care professional:

Coreleader Algi-Fiber wound dressing is indicated as a primary dressing for the management of moderate to heavily exuding wounds, partial and full thickness wounds including chronic wounds such as leg ulcers, pressure sores and acute wounds such as donor sites, abrasions, lacerations and post-surgical wounds.

The following conditions are considered appropriate for OTC use by the lay person:

Coreleader Algi-Fiber wound dressing is indicated as a primary dressing for the management of minor exuding wounds such as minor abrasions, minor lacerations and minor post-surgical wounds.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102943 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102943: Coreleader Algi-Fiber Wound Dressing Model Adw 05050.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102943

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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