510(k) · Cleared

Cleared

Sklar Surgical Gown

K082479510(k) TraditionalCleared Apr 24, 2009239-day reviewClass II21 CFR 878.4040

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

Cleared on Apr 24, 2009 as substantially equivalent to K070431 (Welmed, Inc., 2007) after a 239-day review. Its family tree reaches back 3 generations to 2003.

Decided: Apr 24, 2009
Review: 239 days
Class: Class II
Product code: FYA
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K030364 (2003). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK030364 Deroyal Gowns, Sterile, Non-SterileDeroyal Industries, Inc. · 2003
2 generations backK052550 Imc Surgical GownsIntl. Medsurg Connection, Inc. · 2005
1 generation backK070431 Welmed, Inc. Surgical GownsWelmed, Inc. · 2007
This deviceK082479 Sklar Surgical GownSklar Corp. · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K030364	Deroyal Gowns, Sterile, Non-Sterile	Deroyal Industries, Inc.	2003	—
−2	K052550	Imc Surgical Gowns	Intl. Medsurg Connection, Inc.	2005	—
−1	K070431	Welmed, Inc. Surgical Gowns	Welmed, Inc.	2007	—
0 (this device)	K082479	Sklar Surgical Gown	Sklar Corp.	2009	—

FIG. 1 — Lineage of K082479, 2003–2009Source: 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 FYA? 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 FYA device

#1 K211422 Level 2 Standard Surgical Gown, Level 3…score 20.8 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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
*	K070431	Welmed, Inc. Surgical Gowns Summary page 1 …Product Code: FYA (Surgical Apparel) 3. Predicate Device Information: Welmed Inc. Surgical Gowns - K070431 4. Device Description: The Sklar Surgical Gown is an open back gown manufactured from a non-woven fabric.…	Welmed, Inc.	2007	—

Also cleared against K070431: 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 6 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K070431.

How does its category compare?

All FYA devices

FYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · FYA

4in 2025

2007high 24 (2022) · low 2 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FYA

210in 2025

2007high 275 (2015) · low 98 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FYA

1in 2025

2007high 40 (2020) · low 0 (2008)2026

Class I (9 since 2007) Class II/III not classified

Adverse event reports per year · FYA

14in 2025

2007high 98 (2018) · low 3 (2008)2025

MAUDE reports naming product code FYA, 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	6	110	2	8
2008	4	207	0	3
2009	6	98	0	18
2010	4	128	2	9
2011	8	141	0	16
2012	4	202	1	43
2013	2	—	0	71
2014	5	120	9 (9)	42
2015	3	275	0	59
2016	3	155	0	43
2017	4	111	0	66
2018	2	—	1	98
2019	5	105	0	38
2020	7	114	40	31
2021	17	163	11	15
2022	24	177	2	4
2023	12	190	1	12
2024	5	163	0	27
2025	4	210	1	14
2026	9	198	2	—

What is it indicated for?

The Sklar Surgical Gown is a disposable item that is intended to be used in the operating room as a protective covering, for operating room staff, from the transfer of body fluids and particulates.

The Sklar Surgical Gown is provided as sterile and non-sterile.

Sterile gowns are to be sold directly to users following EtO sterilization validation according to ISO 11135-1:2007. Non-sterile gowns are to be sold to OEMs for EtO sterilization according to ISO 11135-1:2007.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082479 · printed Nov 4, 2026

Cite this page

510(k) Report. “K082479: Sklar Surgical Gown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082479

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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