510(k) · Cleared

Cleared

Coreleader Algiplaster Model AP 050501

K102942510(k) TraditionalCleared Jun 22, 2011261-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 Jun 22, 2011 as substantially equivalent to K910059 (Calgon Vestal Div., 1991) and 1 other predicate after a 261-day review. Its family tree reaches back 2 generations to 1995.

Decided: Jun 22, 2011
Review: 261 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 deviceK102942 Coreleader Algiplaster Model AP 050501Coreleader 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)	K102942	Coreleader Algiplaster Model AP 050501	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 K102942, 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

Get a 510(k) Report

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 …Topical Wound Dressing Name: Classification: Unclassified Classification Hydrophilic Wound and Burn Dressing Name: Predicate CALGON VESTAL DIV., K91 0059, 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., K91 0059, KALTOSTAT WOUND Device: DRESSING COLOPLAST CORP., K9835 19, COMFEEL SEASORB DRESSING _______…	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 12.5 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 conditions are considered appropriate for OTC use by the lay person:

Coreleader AlgiPlaster is indicated for the management minor abrasions, minor cuts and minor lacerations.

The following conditions are considered appropriate for Prescription Use under the supervision of a licensed healthcare provider:

Coreleader Algilaster is indicated as a primary dressing for the management of exuding wounds, including acute wounds such as abrasions, lacerations and post-surgical wounds.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102942 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102942: Coreleader Algiplaster Model AP 050501.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102942

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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