510(k) · Cleared

Cleared

Barrier Surgical Gown with Symetry Fabric

K920996510(k) TraditionalCleared May 31, 199290-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

Johnson & Johnson Medical, Inc. · FYA Gown, Surgical

Cleared on May 31, 1992 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided: May 31, 1992
Review: 90 days
Class: Class II
Product code: FYA
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK920996 Barrier Surgical Gown with Symetry FabricJohnson & Johnson Medical, Inc. · 1992
Descendant · cites it directly · 0 of its ownK050786 Barrier Surgical GownsMolnlycke Health Care · 2005

Most influential descendants

Showing 1 of 1 · See all

K050786Barrier Surgical GownsMolnlycke Health Care · 2005 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K920996	Barrier Surgical Gown with Symetry Fabric	Johnson & Johnson Medical, Inc.	1992	—
+1	K050786	Barrier Surgical Gowns	Molnlycke Health Care	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0

FIG. 1 — Lineage of K920996, 1992–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K050786	Barrier Surgical Gowns	Molnlycke Health Care	2005	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?

Of its descendants, K050786 (Molnlycke Health Care, 2005) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FYA devices

FYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

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	—

https://510kreport.com/device/K920996 · printed Nov 4, 2026

Cite this page

510(k) Report. “K920996: Barrier Surgical Gown with Symetry Fabric.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K920996

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026