510(k) · Cleared
ClearedBAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hindernis DE Mexico, S.A.P.I. DE C.V. · FYA Gown, Surgical
Cleared on May 12, 2026 as substantially equivalent to K200522 (O&M Halyard, Inc., 2020) after a 68-day review. Its family tree reaches back 6 generations to 1998.
- Decided
- May 12, 2026
- Review
- 68 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K981393 (1998). No later device cites it as a predicate yet.
- Root · 6 generations backK981393 Microcool Surgical GownKimberly-Clark Corp. · 1998
- 5 generations backK091357 Microcool Surgical Gown, Breathable High Performance KC400Kimberly-Clark Corp. · 2009 · Recalled
- 4 generations backK103406 Microcool Breathable High Performance Surgical GownsKimberly-Clark Corp. · 2010 · Recalled
- 3 generations backK140539 Aero Blue Performance Surgical GownKimberly-Clark Corporation · 2014
- 2 generations backK153255 Aero Chrome* Breathable Performance Surgical GownHalyard Health, Inc. · 2016
- 1 generation backK200522 AERO CHROME* Breathable Performance Surgical GownsO&M Halyard, Inc. · 2020
- This deviceK260725 BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)Hindernis DE Mexico, S.A.P.I. DE C.V. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K981393 | Microcool Surgical Gown | Kimberly-Clark Corp. | 1998 | — |
| −5 | K091357 | Microcool Surgical Gown, Breathable High Performance KC400 | Kimberly-Clark Corp. | 2009 | 2 |
| −4 | K103406 | Microcool Breathable High Performance Surgical Gowns | Kimberly-Clark Corp. | 2010 | 2 |
| −3 | K140539 | Aero Blue Performance Surgical Gown | Kimberly-Clark Corporation | 2014 | — |
| −2 | K153255 | Aero Chrome* Breathable Performance Surgical Gown | Halyard Health, Inc. | 2016 | — |
| −1 | K200522 | AERO CHROME* Breathable Performance Surgical Gowns | O&M Halyard, Inc. | 2020 | — |
| 0 (this device) | K260725 | BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) | Hindernis DE Mexico, S.A.P.I. DE C.V. | 2026 | — |
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 |
|---|---|---|---|
| * | K200522 | AERO CHROME* Breathable Performance Surgical GownsSummary page 6…MER Surgical Gowns (COP01, COP04, COP05, and COP10) described in this premarket notification are substantially equivalent to the following device: (1) K200522, “AERO CHROME Breathable Performance Surgical Gowns”, manufactured by “O & M Halyard Inc” located in Mechanicsville, VA,… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 5 companies; a new generation was cleared every 3.9 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 1 other device also cites its predicate K200522.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
BAUMER Surgical Gowns (COP01, COP04, COP0S5, and COP10) are intended to be worn by healthcare professionals to help protect both the patients and the healthcare professionals from the transfer of microorganisms, body fluids, and particulate material.
They are classified as Level 4 surgical gowns in accordance with ANSI/AAMI PB70 and used in healthcare facilities. The gowns are single use, disposable, and provided sterile.
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/K260725 · printed Nov 4, 2026
Cite this page
510(k) Report. “K260725: BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K260725
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026