510(k) · Cleared

Cleared

Microcool Surgical Gown

K981393510(k) TraditionalCleared Jul 10, 199884-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

Kimberly-Clark Corp. · FYA Gown, Surgical

Cleared on Jul 10, 1998 after an 84-day review. The FDA summary names its predicate without a number. 13 later devices descend from it.

Decided: Jul 10, 1998
Review: 84 days
Class: Class II
Product code: FYA
Recalls: None
Predicates: 0

13 later devices descend from it, 3 citing it directly.

This deviceK981393 Microcool Surgical GownKimberly-Clark Corp. · 1998
Descendant · cites it directly · 8 of its ownK091357 Microcool Surgical Gown, Breathable High Performance KC400Kimberly-Clark Corp. · 2009 · Recalled
Descendant · 2 generations on · 7 of its ownK103406 Microcool Breathable High Performance Surgical GownsKimberly-Clark Corp. · 2010 · Recalled
Descendant · 3 generations on · 6 of its ownK140539 Aero Blue Performance Surgical GownKimberly-Clark Corporation · 2014
Descendant · 4 generations on · 4 of its ownK153255 Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc. · 2016
Descendant · 5 generations on · 2 of its ownK200522 AERO CHROME* Breathable Performance Surgical GownsO&M Halyard, Inc. · 2020

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2009high 2 (2016) · low 0 (2011)2026

Most influential descendants

Showing 5 of 13 · See all

K091357Microcool Surgical Gown, Breathable High Performance KC400Kimberly-Clark Corp. · 2009 · cites it directly8descendants
K103406Microcool Breathable High Performance Surgical GownsKimberly-Clark Corp. · 2010 · 2 generations on7descendants
K140539Aero Blue Performance Surgical GownKimberly-Clark Corporation · 2014 · 3 generations on6descendants
K153255Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc. · 2016 · 4 generations on4descendants
K200522AERO CHROME* Breathable Performance Surgical GownsO&M Halyard, Inc. · 2020 · 5 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K981393	Microcool Surgical Gown	Kimberly-Clark Corp.	1998	—
+1	K091357	Microcool Surgical Gown, Breathable High Performance KC400	Kimberly-Clark Corp.	2009	2
+2	K103406	Microcool Breathable High Performance Surgical Gowns	Kimberly-Clark Corp.	2010	2
+3	K140539	Aero Blue Performance Surgical Gown	Kimberly-Clark Corporation	2014	—
+4	K153255	Aero Chrome* Breathable Performance Surgical Gown	Halyard Health, Inc.	2016	—
+5	K200522	AERO CHROME* Breathable Performance Surgical Gowns	O&M Halyard, Inc.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	1	0
2014	1	0
2016	2	0
2017	1	0
2018	1	0
2019	1	0
2020	1	0
2021	1	0
2022	1	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K981393, 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
*	—	3M Prevention Fabric Surgical Gown Named without a submission number			—

What descends from it? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K091357	Microcool Surgical Gown, Breathable High Performance KC400	Kimberly-Clark Corp.	2009	8
K160361	PRIMAGARD Isolation Gown (AAMI PB70 Level 3)	Primed Medical Products, Inc.	2016	2
K172954	Medline Prevention CoolZone Gown	Medline Industries, 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?

Of its descendants, K091357 (Kimberly-Clark Corp., 2009) has gone furthest, with 8 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	—

What is it indicated for?

The MicroCool Surgical Gown and the MicroCool Isolation Gown are single use items of surgical apparel intended to be worn by health care professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.

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/K981393 · printed Nov 6, 2026

Cite this page

510(k) Report. “K981393: Microcool Surgical Gown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981393

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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