510(k) · Cleared

Cleared

Exsalt SD7 Wound Dressing

K083870510(k) TraditionalCleared Jul 30, 2009213-day reviewClass U

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

Exciton Technologies, Inc. · FRO Dressing, Wound, Drug

Cleared on Jul 30, 2009 as substantially equivalent to K001519 (Westaim Biomedical, Inc., 2000) after a 213-day review. Its family tree reaches back 1 generation to 2000. 12 later devices descend from it.

Decided: Jul 30, 2009
Review: 213 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K001519 (2000). 12 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK001519 Acticoat 7 DressingWestaim Biomedical, Inc. · 2000
This deviceK083870 Exsalt SD7 Wound DressingExciton Technologies, Inc. · 2009
Descendant · cites it directly · 6 of its ownK100261 Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldTei Biosciences, Inc. · 2010 · Recalled
Descendant · 2 generations on · 4 of its ownK120605 Permacol Surgical ImplantCovidien, LLC · 2012
Descendant · cites it directly · 3 of its ownK103067 Exsalt SD7 Wound DressingExciton Technologies, Inc. · 2011
Descendant · 3 generations on · 1 of its ownK160181 Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC · 2016
Descendant · 3 generations on · 1 of its ownK133011 Diaphragmatic Hernia GraftCook Biotech, Inc. · 2014 · Recalled

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2010high 2 (2010) · low 0 (2013)2026

Most influential descendants

Showing 5 of 12 · See all

K100261Primatrix AG Antimicrobial Dermal Dermal Repair ScaffoldTei Biosciences, Inc. · 2010 · cites it directly6descendants
K120605Permacol Surgical ImplantCovidien, LLC · 2012 · 2 generations on4descendants
K103067Exsalt SD7 Wound DressingExciton Technologies, Inc. · 2011 · cites it directly3descendants
K160181Colorado Therapeutics Xenograft ImplantColorado Therapeutics, LLC · 2016 · 3 generations on1descendant
K133011Diaphragmatic Hernia GraftCook Biotech, Inc. · 2014 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001519	Acticoat 7 Dressing	Westaim Biomedical, Inc.	2000	—
0 (this device)	K083870	Exsalt SD7 Wound Dressing	Exciton Technologies, Inc.	2009	—
+1	K100261	Primatrix AG Antimicrobial Dermal Dermal Repair Scaffold	Tei Biosciences, Inc.	2010	3
+2	K120605	Permacol Surgical Implant	Covidien, LLC	2012	—
+1	K103067	Exsalt SD7 Wound Dressing	Exciton Technologies, Inc.	2011	—
+3	K160181	Colorado Therapeutics Xenograft Implant	Colorado Therapeutics, LLC	2016	—
+3	K133011	Diaphragmatic Hernia Graft	Cook Biotech, Inc.	2014	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	2	0
2011	2	0
2012	1	0
2014	2	0
2016	1	0
2017	2	0
2018	2	0

FIG. 1 — Lineage of K083870, 2000–2018Source: 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
*	K001519	Acticoat 7 Dressing	Westaim Biomedical, Inc.	2000	—

Also cleared against K001519: 8 other devices →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K100261	Primatrix AG Antimicrobial Dermal Dermal Repair Scaffold	Tei Biosciences, Inc.	2010	6
K103067	Exsalt SD7 Wound Dressing	Exciton Technologies, Inc.	2011	3
K113564	Exsalt T7 Wound Dressing	Exciton Technologies, Inc.	2011	1
K100580	Exsalt Wound Dressing	Exciton Technologies, Inc.	2010	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?

Its one ancestor has no recall.
Of its descendants, K100261 (Tei Biosciences, Inc., 2010) has gone furthest, with 6 descendants of its own.
8 other devices also cite its predicate K001519.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

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 exSALT SD7 Wound Dressing is indicated for the management of partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K083870 · printed Nov 5, 2026

Cite this page

510(k) Report. “K083870: Exsalt SD7 Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083870

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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