510(k) · Cleared
ClearedAERO CHROME* Breathable 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 Mar 16, 2020 as substantially equivalent to K153255 (Halyard Health, Inc., 2016) after a 14-day review. Its family tree reaches back 5 generations to 1998. 2 later devices descend from it.
- Decided
- Mar 16, 2020
- Review
- 14 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K981393 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK981393 Microcool Surgical GownKimberly-Clark Corp. · 1998
- 4 generations backK091357 Microcool Surgical Gown, Breathable High Performance KC400Kimberly-Clark Corp. · 2009 · Recalled
- 3 generations backK103406 Microcool Breathable High Performance Surgical GownsKimberly-Clark Corp. · 2010 · Recalled
- 2 generations backK140539 Aero Blue Performance Surgical GownKimberly-Clark Corporation · 2014
- 1 generation backK153255 Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc. · 2016
- This deviceK200522 AERO CHROME* Breathable Performance Surgical GownsO&M Halyard, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK260725 BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V. · 2026
- Descendant · cites it directly · 0 of its ownK210688 AERO CHROME* Select Breathable Performance Surgical Gown, AERO…O&M Halyard, Inc. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K981393 | Microcool Surgical Gown | Kimberly-Clark Corp. | 1998 | — |
| −4 | K091357 | Microcool Surgical Gown, Breathable High Performance KC400 | Kimberly-Clark Corp. | 2009 | 2 |
| −3 | K103406 | Microcool Breathable High Performance Surgical Gowns | Kimberly-Clark Corp. | 2010 | 2 |
| −2 | K140539 | Aero Blue Performance Surgical Gown | Kimberly-Clark Corporation | 2014 | — |
| −1 | K153255 | Aero Chrome* Breathable Performance Surgical Gown | Halyard Health, Inc. | 2016 | — |
| 0 (this device) | K200522 | AERO CHROME* Breathable Performance Surgical Gowns | O&M Halyard, Inc. | 2020 | — |
| +1 | K260725 | BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) | Hindernis DE Mexico, S.A.P.I. DE C.V. | 2026 | — |
| +1 | K210688 | AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line… | O&M Halyard, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2026 | 1 | 0 |
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 |
|---|---|---|---|
| * | K153255 | Aero Chrome* Breathable Performance Surgical GownSummary page 5…FYA FDA Device Classification: Class II FDA Device Name: Gown, Surgical FDA Regulation Number: 21 CFR 878.4040 Predicate Device: K153255 – AERO CHROME* Breathable Performance Surgical Gowns… | 2016 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K260725 (Hindernis DE Mexico, S.A.P.I. DE C.V., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K153255.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 CHROME* Breathable 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 CHROME* Breathable Performance Surgical Gowns meet the Level 4 AAMI PB70:2012 Liquid Barrier classifications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200522 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200522: AERO CHROME* Breathable 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/K200522
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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