510(k) · Cleared
Recalled · Class II · 2023Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · FYA Gown, Surgical
Cleared on Apr 24, 2019 as substantially equivalent to K080795 (Kimberly-Clark Corp., 2008) after a 257-day review. Its family tree reaches back 1 generation to 2008. 2 later devices descend from it. It has been recalled once.
- Decided
- Apr 24, 2019
- Review
- 257 days
- Class
- Class II
- Product code
- FYA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K080795 (2008). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK080795 Ultra Surgical Gown & Fluid Barrier Surgical GownKimberly-Clark Corp. · 2008
- This deviceK182172 Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown…Medline Industries, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK252301 Henan Yadu Level 4 Surgical Gowns (Reinforced)Yadu Medical (Henan) Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK242844 Medline Level 4 Surgical Gown with Breathable SleevesMedline Industries, LP · 2025
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 |
|---|---|---|---|---|---|
| −1 | K080795 | Ultra Surgical Gown & Fluid Barrier Surgical Gown | Kimberly-Clark Corp. | 2008 | — |
| 0 (this device) | K182172 | Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown… | Medline Industries, Inc. | 2019 | — |
| +1 | K252301 | Henan Yadu Level 4 Surgical Gowns (Reinforced) | Yadu Medical (Henan) Co., Ltd. | 2026 | — |
| +1 | K242844 | Medline Level 4 Surgical Gown with Breathable Sleeves | Medline Industries, LP | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K080795 | Ultra Surgical Gown & Fluid Barrier Surgical GownSummary page 5…510(k) Premarket Submission Northfield, IL 60093 All information on this page is confidential K080795 (Kimberly-Clark Corp./Halyard) Device Description The Medline Level 4 Surgical Gown (Sirus, Eclipse, and Aurora) is a Class II m… | 2008 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 29, 2023 | Class II | Z-0711-2024 | Process control | Surgical gowns were manufactured with the wrong sleeve. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), and Medline Level 4 Surgical Gown (Aurora) is a 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 Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), and Medline Level 4 Surgical Gown (Aurora) meets the Level 4 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182172: Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182172
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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