510(k) · Cleared

Cleared

Biatain Foam Dressing

K983163510(k) TraditionalCleared Dec 16, 199897-day reviewClass U

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

Coloplast Corp. · FRO Dressing, Wound, Drug

Cleared on Dec 16, 1998 as substantially equivalent to K871166 (Smith & Nephew, Inc., 1987) after a 97-day review. Its family tree reaches back 1 generation to 1987. 33 later devices descend from it.

Decided: Dec 16, 1998
Review: 97 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K871166 (1987). 33 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK871166 Allevyn Hydrophilic Polyurethane DressingSmith & Nephew, Inc. · 1987
This deviceK983163 Biatain Foam DressingColoplast Corp. · 1998
Descendant · cites it directly · 32 of its ownK022416 Contreet Foam Adhesive/Non-AdhesiveColoplast Corp. · 2003
Descendant · 2 generations on · 17 of its ownK033869 Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004
Descendant · 2 generations on · 11 of its ownK100218 Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM…Coloplast A/S · 2010
Descendant · 2 generations on · 6 of its ownK062559 Urgocell AG Antimicrobial Wound Dressing with SilverLaboratoires Urgo · 2007
Descendant · 3 generations on · 5 of its ownK140954 Luofucon Silver PU Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2015

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2003high 5 (2024) · low 0 (2005)2026

Most influential descendants

Showing 5 of 33 · See all

K022416Contreet Foam Adhesive/Non-AdhesiveColoplast Corp. · 2003 · cites it directly32descendants
K033869Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004 · 2 generations on17descendants
K100218Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMColoplast A/S · 2010 · 2 generations on11descendants
K062559Urgocell AG Antimicrobial Wound Dressing with SilverLaboratoires Urgo · 2007 · 2 generations on6descendants
K140954Luofucon Silver PU Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2015 · 3 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K871166	Allevyn Hydrophilic Polyurethane Dressing	Smith & Nephew, Inc.	1987	—
0 (this device)	K983163	Biatain Foam Dressing	Coloplast Corp.	1998	—
+1	K022416	Contreet Foam Adhesive/Non-Adhesive	Coloplast Corp.	2003	—
+2	K033869	Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)	Coloplast Corp.	2004	—
+2	K100218	Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM	Coloplast A/S	2010	—
+2	K062559	Urgocell AG Antimicrobial Wound Dressing with Silver	Laboratoires Urgo	2007	—
+3	K140954	Luofucon Silver PU Antibacterial Foam Dressing	Huizhou Foryou Medical Devices Co., Ltd.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	3	0
2007	3	0
2009	1	0
2010	4	0
2012	1	0
2013	1	0
2014	3	0
2015	1	0
2016	1	0
2017	1	0
2019	1	0
2020	2	0
2022	1	0
2023	3	0
2024	5	0
2026	1	0

FIG. 1 — Lineage of K983163, 1987–2026Source: 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? (1)

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
*	K871166	Allevyn Hydrophilic Polyurethane Dressing Summary page 1 …Wound Dressing DEVICE CLASSIFICATION: Unclassified PRODUCT CLASSIFCATION: 79FRO PREDICATE DEVICE: Allevyn hydrocellular polyurethane dressing (Smith & Nephew Ltd. UK); K871166. DEVICE DESCRIPTION: The Biatain Foam Dressing is a highly absorbent 3-D polymer dressing consisting of a Polyurethane foam wit…	Smith & Nephew, Inc.	1987	—

Also cleared against K871166: 1 other device →

What descends from it? (33)

See all 33

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

Number	Device	Applicant	Decided	Descendants
K022416	Contreet Foam Adhesive/Non-Adhesive	Coloplast Corp.	2003	32

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?

Its one ancestor has no recall.
Of its descendants, K022416 (Coloplast Corp., 2003) has gone furthest, with 32 descendants of its own.
1 other device also cites its predicate K871166.

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?

The Biatain Foam Dressing is indicated for use in the management of low to highly exudating leg ulcers, skin tears, and pressure sores. The dressing can also be used for 2nd degree burns, 2nd degree partial thickness burns, donor sites, post operative wounds and skin abrasions.

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/K983163 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983163: Biatain Foam Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983163

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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