510(k) · Cleared

Cleared

Procellera

K130350510(k) TraditionalCleared Jul 2, 2013140-day reviewClass U

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

Vomaris Innovations, Inc. · FRO Dressing, Wound, Drug

Cleared on Jul 2, 2013 as substantially equivalent to K081977 (Silverleaf Medical Products, Inc., 2008) and 1 other predicate after a 140-day review. Its family tree reaches back 4 generations to 1992. 2 later devices descend from it.

Decided: Jul 2, 2013
Review: 140 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K914579 (1992). 8 ancestors in all. 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
3 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
2 generations backK060237 CMB Antimicrobial DressingSilverleaf Medical Products, Inc. · 2006
1 generation backK081977 Prosit Wound Treatment DeviceSilverleaf Medical Products, Inc. · 2008
This deviceK130350 ProcelleraVomaris Innovations, Inc. · 2013
Descendant · cites it directly · 1 of its ownK160783 ProcelleraVomaris Innovations, Inc. · 2016
Descendant · cites it directly · 0 of its ownK180533 Procellera Composite Antibacterial Wound DressingVomaris Wound Care, Inc. · 2018

Most influential descendants

Showing 2 of 2 · See all

K160783ProcelleraVomaris Innovations, Inc. · 2016 · cites it directly1descendant
K180533Procellera Composite Antibacterial Wound DressingVomaris Wound Care, Inc. · 2018 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K914579	Silver Foam Wound Dressing	Vitaphore Corp.	1992	—
−3	K955453	Acticoat Silver Coated Dressing	Westaim Technologies, Inc.	1996	—
−2	K060237	CMB Antimicrobial Dressing	Silverleaf Medical Products, Inc.	2006	—
−1	K081977	Prosit Wound Treatment Device	Silverleaf Medical Products, Inc.	2008	—
0 (this device)	K130350	Procellera	Vomaris Innovations, Inc.	2013	—
+1	K160783	Procellera	Vomaris Innovations, Inc.	2016	—
+1	K180533	Procellera Composite Antibacterial Wound Dressing	Vomaris Wound Care, Inc.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1997	2	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0
2018	1	0

FIG. 1 — Lineage of K130350, 1992–2018Source: 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? (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
*	K081977	Prosit Wound Treatment Device Summary page 2 …Phone: 480-921-4948 Fax: 480-921-0948 Technological Characteristics: Procellera® device is identical to the device cleared under 5 10(k) K060237 and K08 1977. Elemental silver and elemental zinc are bound to the surface of a polyester substrate in a well-characterized dot matrix pattern…	Silverleaf Medical Products, Inc.	2008	—
*	K060237	CMB Antimicrobial Dressing Summary page 1 …lera® Wound Dressing Trade Name: Procellera®) Common Name: Wound Dressing Product Code: FRO Predicate Devices: Procellera®0 wound dressing (KOS 1977) CMBTM dressing (K060237) Device Description: Procellera® is a single layer dressing; it consists of a polyester substrate containing elemental silver…	Silverleaf Medical Products, Inc.	2006	—

Also cleared against K081977: 2 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K160783	Procellera	Vomaris Innovations, Inc.	2016	1
K180533	Procellera Composite Antibacterial Wound Dressing	Vomaris Wound Care, Inc.	2018	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?

The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
1 of the 8 ancestors has a recall of any class.
Of its descendants, K160783 (Vomaris Innovations, Inc., 2016) has gone furthest, with 1 descendant of its own.
2 other devices also cite its predicate K081977.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?

For prescription use, Procellera® antimicrobial wound dressing is intended for the management of wounds to provide a moist wound environment and is indicated for partial and full-thickness wounds such as pressure ulcers, venous ulcers, diabetic ulcers, first and second degree burns, surgical incisions, donor and/or recipient graft sites, etc.

For over-the-counter use, Procellera® wound dressing is intended for the management of wounds to provide a moist wound environment and is indicated for superficial wounds such as minor cuts, scrapes, irritations, abrasions, blisters, etc.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K130350 · printed Nov 4, 2026

Cite this page

510(k) Report. “K130350: Procellera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130350

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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