510(k) · Cleared

Cleared

Fibrcol Plus Collagen Wound Dressing with Alginate

K982597510(k) TraditionalCleared Aug 20, 199827-day reviewClass U

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

Johnson & Johnson Medical, Inc. · KGN Wound Dressing With Animal-Derived Material (S)

Cleared on Aug 20, 1998 as substantially equivalent to K925548 (Johnson & Johnson Medical, Inc., 1993) and 2 other predicates after a 27-day review. Its family tree reaches back 1 generation to 1988. 253 later devices descend from it.

Decided: Aug 20, 1998
Review: 27 days
Class: Class U
Product code: KGN
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K881854 (1988). 3 ancestors in all. 253 later devices descend from it, 8 citing it directly.

By dateBy generation

Root · 1 generation backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
This deviceK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
Descendant · cites it directly · 235 of its ownK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
Descendant · 2 generations on · 173 of its ownK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
Descendant · 3 generations on · 102 of its ownK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
Descendant · 3 generations on · 91 of its ownK031969 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003
Descendant · cites it directly · 77 of its ownK014129 Promogran Matrix Wound DressingJohnson & Johnson Medical, Ltd. · 2002

Showing 5 of 253 descendants. See all descendants

Descendants cleared per year

2000high 17 (2017) · low 0 (2001)2026

Most influential descendants

Showing 5 of 253 · See all

K993948Sis Wound Dressing IICook Biotech, Inc. · 2000 · cites it directly235descendants
K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000 · 2 generations on173descendants
K020049Fortaflex Surgical MeshOrganogenesis, Inc. · 2002 · 3 generations on102descendants
K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003 · 3 generations on91descendants
K014129Promogran Matrix Wound DressingJohnson & Johnson Medical, Ltd. · 2002 · cites it directly77descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K881854	Sorbsan Topical Wound Dressing	E.G. Dick & Assoc.	1988	—
0 (this device)	K982597	Fibrcol Plus Collagen Wound Dressing with Alginate	Johnson & Johnson Medical, Inc.	1998	—
+1	K993948	Sis Wound Dressing II	Cook Biotech, Inc.	2000	—
+2	K001738	Depuy Restore Orthobiologic Soft Tissue Implant	DePuy Orthopaedics, Inc.	2000	—
+3	K020049	Fortaflex Surgical Mesh	Organogenesis, Inc.	2002	—
+3	K031969	Depuy Restore Orthobiologic Soft Tissue Implant	DePuy Orthopaedics, Inc.	2003	—
+1	K014129	Promogran Matrix Wound Dressing	Johnson & Johnson Medical, Ltd.	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
1993	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	2	0
2002	8	0
2003	4	0
2004	5	0
2005	4	0
2006	10	0
2007	12	0
2008	12	0
2009	15	0
2010	12	0
2011	14	0
2012	12	0
2013	9	0
2014	11	0
2015	7	0
2016	9	0
2017	17	0
2018	9	0
2019	7	0
2020	4	0
2021	8	0
2022	11	0
2023	8	0
2024	14	0
2025	16	0
2026	13	0

FIG. 1 — Lineage of K982597, 1988–2026Source: 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 KGN? 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 KGN device

#1 K231325 Corplex P / Theracor P / Allacor Pscore 17.9 · 8 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
*	K925548	Fibracol Collagen-Alginate Dressing Summary page 1 …STANTIAL EQUIVALENCE FIBRACOL* PLUS Collagen Wound Dressing with Alginate is substantially equivalent and identical in function to FIBRACOL* Collagen-Alginate Dressing (K925548) manufactured by Johnson & Johnson Medical, and SORBSAN Topical Wound Dressing (K881854 Steriseal) & (K914575 Dow B. Hickam) Dist…	Johnson & Johnson Medical, Inc.	1993	—
*	K881854	Sorbsan Topical Wound Dressing Summary page 1 …lly equivalent and identical in function to FIBRACOL* Collagen-Alginate Dressing (K925548) manufactured by Johnson & Johnson Medical, and SORBSAN Topical Wound Dressing (K881854 Steriseal) & (K914575 Dow B. Hickam) Distributed by Dow Hickam Pharmaceuticals, inc. 7. INDICATIONS FOR USE FIBRACOL* PLUS Dres…	E.G. Dick & Assoc.	1988	—
*	K914575	Sorbsan Topical Wound Dressing (Modified) Summary page 1 …ntical in function to FIBRACOL* Collagen-Alginate Dressing (K925548) manufactured by Johnson & Johnson Medical, and SORBSAN Topical Wound Dressing (K881854 Steriseal) & (K914575 Dow B. Hickam) Distributed by Dow Hickam Pharmaceuticals, inc. 7. INDICATIONS FOR USE FIBRACOL* PLUS Dressing is indicated for…	Dow B. Hickam, Inc.	1991	—

Also cleared against K925548: 3 other devices →

What descends from it? (253)

See all 253

8 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K993948	Sis Wound Dressing II	Cook Biotech, Inc.	2000	235
K014129	Promogran Matrix Wound Dressing	Johnson & Johnson Medical, Ltd.	2002	77
K023778	Dressskin	Tei Biosciences, Inc.	2003	31
K040283	Biopad	Euroresearch Srl	2005	28
K020732	SS Matrix	Cook Biotech, Inc.	2002	5
K242985	CollOvine™ Wound Dressing	Ovigenex, LLC	2025	0
K111578	Coreleader Colla-Algi Fiber Model Caw	Coreleader Biotech Co., Ltd.	2011	0
K040314	Healicoll	Encoll Corp.	2004	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, K993948 (Cook Biotech, Inc., 2000) has gone furthest, with 235 descendants of its own.
3 other devices also cite its predicate K925548.

How does its category compare?

All KGN devices

KGN Wound Dressing With Animal-Derived Material (S): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGN

15so far in 2026, the most since 2007

2007high 15 (2026) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KGN

162in 2025

2007high 279 (2020) · low 32 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KGN

3in 2018

2007high 3 (2018) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KGN

15in 2025

2007high 21 (2023) · low 0 (2007)2025

MAUDE reports naming product code KGN, 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	3	32	0	0
2008	6	87	0	1
2009	8	121	0	2
2010	4	175	0	3
2011	7	228	0	6
2012	8	123	0	4
2013	6	147	0	6
2014	5	188	0	12
2015	7	87	0	9
2016	4	164	0	6
2017	7	136	1	8
2018	6	148	3	15
2019	3	128	0	11
2020	5	279	0	17
2021	6	236	0	14
2022	12	246	0	13
2023	9	194	0	21
2024	13	83	0	15
2025	10	162	0	15
2026	15	174	0	—

What is it indicated for?

FIBRACOL* PLUS Dressing is indicated for the management of exuding wounds including: Full thickness & partial thickness wounds Pressure Ulcers Venous ulcers Ulcers caused by mixed vascular etiologies Diabetic ulcers Second-degree burns Donor sites and other bleeding surface wounds Abrasions Traumatic wounds healing by secondary intention Dehisced surgical incisions Precautions: FIBRACOL PLUS Dressing may be used when visible signs of infection are…

Read the full statement (111 words)

FIBRACOL* PLUS Dressing is indicated for the management of exuding wounds including:

Full thickness & partial thickness wounds

Pressure Ulcers

Venous ulcers

Ulcers caused by mixed vascular etiologies

Diabetic ulcers

Second-degree burns

Donor sites and other bleeding surface wounds

Abrasions

Traumatic wounds healing by secondary intention

Dehisced surgical incisions

Precautions:

FIBRACOL PLUS Dressing may be used when visible signs of infection are present in the wound area only when proper medical treatment addresses the underlying cause. FIBRACOL PLUS Dressing may be used under compression therapy with healthcare profession supervision.

Contraindications:

FIBRACOL PLUS is not indicated for wounds with active vasculitis, third-degree burns, or patients with known sensitivity to collagen or alginates.

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/K982597 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982597: Fibrcol Plus Collagen Wound Dressing with Alginate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982597

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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