510(k) · Cleared

Cleared

Dressskin

K023778510(k) AbbreviatedCleared Sep 29, 2003321-day reviewClass U

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

Tei Biosciences, Inc. · KGN Wound Dressing With Animal-Derived Material (S)

Cleared on Sep 29, 2003 as substantially equivalent to K993948 (Cook Biotech, Inc., 2000) and 1 other predicate after a 321-day review. Its family tree reaches back 3 generations to 1988. 31 later devices descend from it.

Decided: Sep 29, 2003
Review: 321 days
Class: Class U
Product code: KGN
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K881854 (1988). 8 ancestors in all. 31 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 3 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
2 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
1 generation backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
This deviceK023778 DressskinTei Biosciences, Inc. · 2003
Descendant · cites it directly · 27 of its ownK061407 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2006
Descendant · 2 generations on · 20 of its ownK083440 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2008
Descendant · cites it directly · 6 of its ownK100261 Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldTei Biosciences, Inc. · 2010 · Recalled
Descendant · 3 generations on · 5 of its ownK132343 Marigen Wound DressingKerecis Limited · 2013
Descendant · cites it directly · 5 of its ownK131286 Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2013

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2006high 3 (2012) · low 0 (2015)2026

Most influential descendants

Showing 5 of 31 · See all

K061407Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2006 · cites it directly27descendants
K083440Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2008 · 2 generations on20descendants
K100261Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldTei Biosciences, Inc. · 2010 · cites it directly6descendants
K132343Marigen Wound DressingKerecis Limited · 2013 · 3 generations on5descendants
K131286Primatrix Dermal Repair ScaffoldTei Biosciences, Inc. · 2013 · cites it directly5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K881854	Sorbsan Topical Wound Dressing	E.G. Dick & Assoc.	1988	—
−2	K982597	Fibrcol Plus Collagen Wound Dressing with Alginate	Johnson & Johnson Medical, Inc.	1998	—
−1	K993948	Sis Wound Dressing II	Cook Biotech, Inc.	2000	—
0 (this device)	K023778	Dressskin	Tei Biosciences, Inc.	2003	—
+1	K061407	Primatrix Dermal Repair Scaffold	Tei Biosciences, Inc.	2006	—
+2	K083440	Primatrix Dermal Repair Scaffold	Tei Biosciences, Inc.	2008	—
+1	K100261	Primatrix AG Antimicrobial Dermal Dermal Repair Scaffold	Tei Biosciences, Inc.	2010	3
+3	K132343	Marigen Wound Dressing	Kerecis Limited	2013	—
+1	K131286	Primatrix Dermal Repair Scaffold	Tei Biosciences, Inc.	2013	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	3	0
1993	1	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2008	1	0
2009	1	0
2010	2	0
2011	1	0
2012	3	0
2013	2	0
2014	2	0
2016	3	0
2017	2	0
2018	1	0
2019	2	0
2021	2	0
2022	1	0
2023	1	0
2024	1	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K023778, 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

Get a 510(k) Report

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
*	K993948	Sis Wound Dressing II Summary page 1 …on and intended use to: Predicate Devices Manufacturer 510(k) Number SIS Wound Dressing I I Cook Biotech K993948 Fibracol Plus Collagen Johnson Et Johnson Medical K982597 Wound Dressing…	Cook Biotech, Inc.	2000	—
*	K982597	Fibrcol Plus Collagen Wound Dressing with Alginate Summary page 1 …turer 510(k) Number SIS Wound Dressing I I Cook Biotech K993948 Fibracol Plus Collagen Johnson Et Johnson Medical K982597 Wound Dressing - 28 - TEI BIOSCIENCESINC.…	Johnson & Johnson Medical, Inc.	1998	—

Also cleared against K993948: 9 other devices →

What descends from it? (31)

See all 31

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

Number	Device	Applicant	Decided	Descendants
K061407	Primatrix Dermal Repair Scaffold	Tei Biosciences, Inc.	2006	27
K100261	Primatrix AG Antimicrobial Dermal Dermal Repair Scaffold	Tei Biosciences, Inc.	2010	6
K131286	Primatrix Dermal Repair Scaffold	Tei Biosciences, Inc.	2013	5
K070557	MP 719	Marine Polymer Technologies, Inc.	2007	2

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?

The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
None of the 8 ancestors has a recall.
Of its descendants, K061407 (Tei Biosciences, Inc., 2006) has gone furthest, with 27 descendants of its own.
9 other devices also cite its predicate K993948.

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?

Dressskin is intended for the management of wounds that include:

Partial and full thickness wounds

Pressure, diabetic, and venous ulcers

Second-degree burns

Surgical wounds-donor sites/grafts, post-moh’s surgery, post-laser surgery, podiatric, wound dehiscence

Trauma wounds-abrasions, lacerations, and skin tears

Tunneled/undermined wounds

Draining wounds

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023778 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023778: Dressskin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023778

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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