510(k) · Cleared

Recalled · Class II · 2009

Microcool Surgical Gown, Breathable High Performance KC400

K091357510(k) AbbreviatedCleared Aug 10, 200994-day reviewClass II21 CFR 878.4040Recalls 2

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

Kimberly-Clark Corp. · FYA Gown, Surgical

Cleared on Aug 10, 2009 as substantially equivalent to K981393 (Kimberly-Clark Corp., 1998) after a 94-day review. Its family tree reaches back 1 generation to 1998. 8 later devices descend from it. It has been recalled 2 times.

Decided: Aug 10, 2009
Review: 94 days
Class: Class II
Product code: FYA
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K981393 (1998). 8 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK981393 Microcool Surgical GownKimberly-Clark Corp. · 1998
This deviceK091357 Microcool Surgical Gown, Breathable High Performance KC400Kimberly-Clark Corp. · 2009
Descendant · cites it directly · 7 of its ownK103406 Microcool Breathable High Performance Surgical GownsKimberly-Clark Corp. · 2010 · Recalled
Descendant · 2 generations on · 6 of its ownK140539 Aero Blue Performance Surgical GownKimberly-Clark Corporation · 2014
Descendant · 3 generations on · 4 of its ownK153255 Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc. · 2016
Descendant · 4 generations on · 2 of its ownK200522 AERO CHROME* Breathable Performance Surgical GownsO&M Halyard, Inc. · 2020
Descendant · 5 generations on · 0 of its ownK260725 BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V. · 2026

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2010high 1 (2010) · low 0 (2011)2026

Most influential descendants

Showing 5 of 8 · See all

K103406Microcool Breathable High Performance Surgical GownsKimberly-Clark Corp. · 2010 · cites it directly7descendants
K140539Aero Blue Performance Surgical GownKimberly-Clark Corporation · 2014 · 2 generations on6descendants
K153255Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc. · 2016 · 3 generations on4descendants
K200522AERO CHROME* Breathable Performance Surgical GownsO&M Halyard, Inc. · 2020 · 4 generations on2descendants
K260725BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V. · 2026 · 5 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K981393	Microcool Surgical Gown	Kimberly-Clark Corp.	1998	—
0 (this device)	K091357	Microcool Surgical Gown, Breathable High Performance KC400	Kimberly-Clark Corp.	2009	—
+1	K103406	Microcool Breathable High Performance Surgical Gowns	Kimberly-Clark Corp.	2010	2
+2	K140539	Aero Blue Performance Surgical Gown	Kimberly-Clark Corporation	2014	—
+3	K153255	Aero Chrome* Breathable Performance Surgical Gown	Halyard Health, Inc.	2016	—
+4	K200522	AERO CHROME* Breathable Performance Surgical Gowns	O&M Halyard, Inc.	2020	—
+5	K260725	BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)	Hindernis DE Mexico, S.A.P.I. DE C.V.	2026	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2014	1	0
2016	1	0
2017	1	0
2019	1	0
2020	1	0
2021	1	0
2026	1	0

FIG. 1 — Lineage of K091357, 1998–2026Source: 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
*	K981393	Microcool Surgical Gown Summary page 1 …ntial Equivalence: The MicroCool* Surgical Gown that is the subject of this 510(k) is substantially equivalent to the predicate Kimberly-Clark* MicroCool* Surgical Gown (K981393) in intended use, design, materials, and biocompatibility attributes. The performance attributes of the MicroCool* Surgical Gown…	Kimberly-Clark Corp.	1998	—

Also cleared against K981393: 2 other devices →

What descends from it? (8)

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

Number	Device	Applicant	Decided	Descendants
K103406	Microcool Breathable High Performance Surgical Gowns	Kimberly-Clark Corp.	2010	7

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 17, 2009	Class II	Z-2018-2012	Process control	Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.
Sep 17, 2009	Class II	Z-2017-2012	Process control	Complaints were received of gowns pilling or balling, linting and abrades, blood strikethrough and fibers falling off the gowns.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K103406 (Kimberly-Clark Corp., 2010) has gone furthest, with 7 descendants of its own.
2 other devices also cite its predicate K981393.

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 Kimberly-Clark* MicroCOOL* Surgical Gowns, are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The MicroCool* Surgical Gown meets the Level 4 requirements of the AAMI Liquid Barrier classifications.

The Kimberly-Clark* MicroCool* Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091357 · printed Nov 5, 2026

Cite this page

510(k) Report. “K091357: Microcool Surgical Gown, Breathable High Performance KC400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091357

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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