510(k) · Cleared

Cleared

Algoplaque Film Extra Thin Hydrocolloid Dressing

K974348510(k) TraditionalCleared Feb 13, 199886-day reviewClass U

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

Laboratoires Urgo S.A. · FRO Dressing, Wound, Drug

Cleared on Feb 13, 1998 as substantially equivalent to K970518 (Laboratoires Urgo S.A., 1997) and 2 other predicates after an 86-day review. Its family tree reaches back 1 generation to 1984. 1 later device descends from it.

Decided: Feb 13, 1998
Review: 86 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K840438 (1984). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK840438 Comfeel Ulcus SheetColoplast A/S · 1984
This deviceK974348 Algoplaque Film Extra Thin Hydrocolloid DressingLaboratoires Urgo S.A. · 1998
Descendant · cites it directly · 0 of its ownK082208 Doctors Choice Slow Healing Bandage with Spray on RemoverScivolutions, Inc. · 2008

Most influential descendants

Showing 1 of 1 · See all

K082208Doctors Choice Slow Healing Bandage with Spray on RemoverScivolutions, Inc. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K840438	Comfeel Ulcus Sheet	Coloplast A/S	1984	—
0 (this device)	K974348	Algoplaque Film Extra Thin Hydrocolloid Dressing	Laboratoires Urgo S.A.	1998	—
+1	K082208	Doctors Choice Slow Healing Bandage with Spray on Remover	Scivolutions, Inc.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1997	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K974348, 1984–2008Source: 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? (3)

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
*	K970518	Algoplaque Hydrocolloid Dressing Summary page 2 …under the additional proprietary name SORBEX Thin. .ZGALLYMARKETED DEV '$i§ VTO WHICH SUBSTANTIAL EOUIVA E NCE i CLAIMED B I e U L = e ALGOPLAQUE Hydrocollo:d Dressmg (K970518 URGO) ¢ DuoDERM Extra Thin CGF Dressing (K925990, ConvaTec) e Comfeel Ulcer Dressing (K840438, Coloplast) -15…	Laboratoires Urgo S.A.	1997	—
*	K925990	Duoderm Extra Thin CGF Dressing Summary page 2 ….ZGALLYMARKETED DEV '$i§ VTO WHICH SUBSTANTIAL EOUIVA E NCE i CLAIMED B I e U L = e ALGOPLAQUE Hydrocollo:d Dressmg (K970518 URGO) ¢ DuoDERM Extra Thin CGF Dressing (K925990, ConvaTec) e Comfeel Ulcer Dressing (K840438, Coloplast) -15 Feb-12-98 01:08P 510(k) SUMMARY Algoplaque Film E…	Convatec, A Division of E.R. Squibb & Sons	1993	—
*	K840438	Comfeel Ulcus Sheet Summary page 2 …AL EOUIVA E NCE i CLAIMED B I e U L = e ALGOPLAQUE Hydrocollo:d Dressmg (K970518 URGO) ¢ DuoDERM Extra Thin CGF Dressing (K925990, ConvaTec) e Comfeel Ulcer Dressing (K840438, Coloplast) -15 Feb-12-98 01:08P 510(k) SUMMARY Algoplaque Film Extra Thin Hydrocolloid Dressing page 3 of 4 D…	Coloplast A/S	1984	—

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K082208	Doctors Choice Slow Healing Bandage with Spray on Remover	Scivolutions, Inc.	2008	0

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 3 ancestors has a recall.
Of its descendants, K082208 (Scivolutions, Inc., 2008) has gone furthest, with 0 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.

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?

Algoplaque Film Extra Thin Hydrocolloid Dressings are intended for the local

management of superficial, dry to lightly-exudating wounds, including superficial

burns, pressure sores, dermal ulcers, post-operative wounds or suture sites,

abrasions and lacerations.

Algoplaque Film Extra Thin Hydrocolloid Dressings are also suitable for use as

protective skin coverings.

Algoplaque Film Extra Thin Hydrocolloid Dressings are not intended for use on

third degree burns.

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

https://510kreport.com/device/K974348 · printed Nov 5, 2026

Cite this page

510(k) Report. “K974348: Algoplaque Film Extra Thin Hydrocolloid Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974348

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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