510(k) · Cleared

Cleared

Sorbsan Topical Wound Dressing

K881854510(k) TraditionalCleared Jul 19, 198877-day reviewClass U

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

E.G. Dick & Assoc. · FRO Dressing, Wound, Drug

Cleared on Jul 19, 1988 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 255 later devices descend from it.

Decided: Jul 19, 1988
Review: 77 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 0

255 later devices descend from it, 2 citing it directly.

This deviceK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
Descendant · cites it directly · 253 of its ownK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
Descendant · 2 generations on · 235 of its ownK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
Descendant · 3 generations on · 173 of its ownK001738 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000
Descendant · 4 generations on · 102 of its ownK020049 Fortaflex Surgical MeshOrganogenesis, Inc. · 2002
Descendant · 4 generations on · 91 of its ownK031969 Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003

Showing 5 of 255 descendants. See all descendants

Descendants cleared per year

1998high 17 (2017) · low 0 (1999)2026

Most influential descendants

Showing 5 of 255 · See all

K982597Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998 · cites it directly253descendants
K993948Sis Wound Dressing IICook Biotech, Inc. · 2000 · 2 generations on235descendants
K001738Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2000 · 3 generations on173descendants
K020049Fortaflex Surgical MeshOrganogenesis, Inc. · 2002 · 4 generations on102descendants
K031969Depuy Restore Orthobiologic Soft Tissue ImplantDePuy Orthopaedics, Inc. · 2003 · 4 generations on91descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K881854	Sorbsan Topical Wound Dressing	E.G. Dick & Assoc.	1988	—
+1	K982597	Fibrcol Plus Collagen Wound Dressing with Alginate	Johnson & Johnson Medical, Inc.	1998	—
+2	K993948	Sis Wound Dressing II	Cook Biotech, Inc.	2000	—
+3	K001738	Depuy Restore Orthobiologic Soft Tissue Implant	DePuy Orthopaedics, Inc.	2000	—
+4	K020049	Fortaflex Surgical Mesh	Organogenesis, Inc.	2002	—
+4	K031969	Depuy Restore Orthobiologic Soft Tissue Implant	DePuy Orthopaedics, Inc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2000	2	0
2001	1	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 K881854, 1988–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (255)

See all 255

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

Number	Device	Applicant	Decided	Descendants
K982597	Fibrcol Plus Collagen Wound Dressing with Alginate	Johnson & Johnson Medical, Inc.	1998	253
K004028	Arglaes-AB Antimicrobial Barrier Powder Dressing	Maersk Medical, Ltd.	2001	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?

Of its descendants, K982597 (Johnson & Johnson Medical, Inc., 1998) has gone furthest, with 253 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	—

https://510kreport.com/device/K881854 · printed Nov 6, 2026

Cite this page

510(k) Report. “K881854: Sorbsan Topical Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K881854

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026