510(k) · Cleared

Cleared

Ialuset Hydrocolloid

K020041510(k) TraditionalCleared Mar 14, 200266-day reviewClass U

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

Institut Biochimique SA (Ibsa) · FRO Dressing, Wound, Drug

Cleared on Mar 14, 2002 as substantially equivalent to K881050 (Convatec, A Division of E.R. Squibb & Sons, 1988) and 1 other predicate after a 66-day review. Its family tree reaches back 1 generation to 1988.

Decided: Mar 14, 2002
Review: 66 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K881050 (1988). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK881050 Duoderm (R) CGFConvatec, A Division of E.R. Squibb & Sons · 1988
This deviceK020041 Ialuset HydrocolloidInstitut Biochimique SA (Ibsa) · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K881050	Duoderm (R) CGF	Convatec, A Division of E.R. Squibb & Sons	1988	—
0 (this device)	K020041	Ialuset Hydrocolloid	Institut Biochimique SA (Ibsa)	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K020041, 1988–2002Source: 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
*	K881050	Duoderm (R) CGF Summary page 1 …g, Wound and Burn, Occlusive (878.4020) Predicate Device TALUSET HYDROCOLLOID is substantially equivalent to two other hydrocolloid wound dressings, one from ConvaTec (K881050) and the other from Innovative Technologies (K971126). Device Description IALUSET HYDROCOLLOID is a 10 cm x 10 cm wound dressin…	Convatec, A Division of E.R. Squibb & Sons	1988	—
*	K971126	Hydrocolloid Wound Dressings Summary page 1 …vice TALUSET HYDROCOLLOID is substantially equivalent to two other hydrocolloid wound dressings, one from ConvaTec (K881050) and the other from Innovative Technologies (K971126). Device Description IALUSET HYDROCOLLOID is a 10 cm x 10 cm wound dressing comprised of an inner layer of hydrocolloids (conta…	Innovative Technologies, Ltd.	1997	—

Also cleared against K881050: 1 other device →

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?

None of the 2 ancestors has a recall.
1 other device also cites its predicate K881050.

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?

For over-the-counter use, IALUSET HYDROCOLLOID may be applied to:

abrasions

lacerations

minor cuts

minor scalds

minor burns

Under the supervision of a physician, IALUSET HYDROCOLLOID may also be applied to:

leg ulcers (venous stasis ulcers, arterial ulcers)

diabetic ulcers

pressure ulcers (stage I - IV)

surgical wounds (postoperative, dermatological excisions, donor sites)

burns (first and second degree only)

traumatic wounds

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/K020041 · printed Nov 3, 2026

Cite this page

510(k) Report. “K020041: Ialuset Hydrocolloid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K020041

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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