510(k) · Cleared

Cleared

Cicanet Wound Contact Layer Dressing - 2 X 3 in. Model 59100600, Cicanet Wound Contact Layer Dressing - 4 X 5 in. MODEL0

K981713510(k) TraditionalCleared Jul 31, 199877-day reviewClass U

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

Smith & Nephew, Inc. · MGP Dressing, Wound And Burn, Occlusive

Cleared on Jul 31, 1998 as substantially equivalent to K973538 (Winfield Laboratories, Inc., 1997) after a 77-day review. Its family tree reaches back 2 generations to 1982.

Decided: Jul 31, 1998
Review: 77 days
Class: Class U
Product code: MGP
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K820198 (1982). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK820198 Derma-AidWinfield Laboratories, Inc. · 1982
1 generation backK973538 N-TerfaceWinfield Laboratories, Inc. · 1997
This deviceK981713 Cicanet Wound Contact Layer Dressing - 2 X 3 in. Model 59100600…Smith & Nephew, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K820198	Derma-Aid	Winfield Laboratories, Inc.	1982	—
−1	K973538	N-Terface	Winfield Laboratories, Inc.	1997	—
0 (this device)	K981713	Cicanet Wound Contact Layer Dressing - 2 X 3 in. Model 59100600, Cicanet Wound…	Smith & Nephew, Inc.	1998	—

FIG. 1 — Lineage of K981713, 1982–1998Source: 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 MGP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against? (5)

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
*	K973538	N-Terface Summary page 2 …, NY TELFA CLEAR™ Nonadherent Wound Dressing Kendall Healthcare Products Mansfield, MA N-TERFACE® Interposttional Surfacing Material Winfield Laboratories Dallas, TX (K973538) Device Descripti CicaNet* Wound Contact Layer Dressing is an air permeable, transparent, bi-axially stretched net constructed…	Winfield Laboratories, Inc.	1997	—
*	—	3M Tegapore™ Wound Contact Material Named without a submission number			—
*	—	DERMANET™ Wound Contact Layer Named without a submission number			—
*	—	Conformant 2™ Transparent, Non-Adherent, Wound Veil Named without a submission number			—
*	—	TELFA CLEAR™ Nonadherent Wound Dressing Named without a submission number			—

Also cleared against K973538: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 16 years and passes through 2 companies; a new generation was cleared every 15.8 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K973538.

How does its category compare?

All MGP devices

MGP Dressing, Wound And Burn, Occlusive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MGP

FDA has decided no MGP device since 2007.

Median 510(k) review, days · MGP

Too few MGP 510(k)s in any year since 2007 to give a median.

Recalls per year · MGP

1in 2011

2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · MGP

8in 2024

2007high 52 (2021) · low 0 (2008)2025

MAUDE reports naming product code MGP, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	1
2008	—	0	0
2009	—	0	1
2010	—	0	2
2011	—	1	4
2012	—	0	0
2013	—	0	7
2014	—	0	1
2015	—	0	3
2016	—	0	1
2017	—	0	6
2018	—	0	0
2019	—	0	0
2020	—	0	0
2021	—	0	52
2022	—	0	3
2023	—	0	3
2024	—	0	8
2025	—	0	0
2026	—	0	—

What is it indicated for?

Wound contact layer dressings are indicated to provide covering for the wound bed.

For OTC applications, CicaNet* Wound Contact Layer Dressing may be used for the management of minor wounds including

Abrasions

Skin tears

Minor burns and scalds

Under the care of a healthcare professional, CicaNet* Wound Contact Layer Dressing may be used in the management of partial and full thickness wounds including:

Leg ulcers

Pressure ulcers

Second degree burns

Surgical wounds

Diabetic foot ulcers

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/K981713 · printed Nov 4, 2026

Cite this page

510(k) Report. “K981713: Cicanet Wound Contact Layer Dressing - 2 X 3 in. Model 59100600, Cicanet Wound Contact Layer Dressing - 4 X 5 in. MODEL0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981713

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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