510(k) · Cleared
Recalled · Class II · 2022Aero Blue Performance Surgical Gowns
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
O&M Halyard, Inc. · FYA Gown, Surgical
Cleared on Dec 13, 2019 as substantially equivalent to K140539 (Kimberly-Clark Corporation, 2014) after a 105-day review. Its family tree reaches back 4 generations to 1998. It has been recalled once.
- Decided
- Dec 13, 2019
- Review
- 105 days
- Class
- Class II
- Product code
- FYA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K981393 (1998). No later device cites it as a predicate yet.
- Root · 4 generations backK981393 Microcool Surgical GownKimberly-Clark Corp. · 1998
- 3 generations backK091357 Microcool Surgical Gown, Breathable High Performance KC400Kimberly-Clark Corp. · 2009 · Recalled
- 2 generations backK103406 Microcool Breathable High Performance Surgical GownsKimberly-Clark Corp. · 2010 · Recalled
- 1 generation backK140539 Aero Blue Performance Surgical GownKimberly-Clark Corporation · 2014
- This deviceK192362 Aero Blue Performance Surgical GownsO&M Halyard, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981393 | Microcool Surgical Gown | Kimberly-Clark Corp. | 1998 | — |
| −3 | 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 |
| −1 | K140539 | Aero Blue Performance Surgical Gown | Kimberly-Clark Corporation | 2014 | — |
| 0 (this device) | K192362 | Aero Blue Performance Surgical Gowns | O&M Halyard, Inc. | 2019 | — |
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
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 | Decided |
|---|---|---|---|
| * | K140539 | Aero Blue Performance Surgical GownSummary page 5…FDA Device Classification: Class II FDA Device Name: Gown, Surgical FDA Regulation Number: 21 CFR 878.4040 Predicate Device: K140539 - Aero Blue Performance Surgical Gowns Device Description: The Aero Blue Performance Surgical Gowns have a SMS/F/SMS… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 31, 2022 | Class II | Z-0343-2023 | Under Investigation by firm | Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K140539.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · FYA
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FYA
210in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FYA
1in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · FYA
14in 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 Aero Blue Performance 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 Aero Blue Performance Surgical Gowns meet the Level 3 AAMI PB70:2012 Liquid Barrier classifications.
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/K192362 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192362: Aero Blue Performance Surgical Gowns.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192362
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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