510(k) · Cleared
ClearedEndoArmor™ + Surgical Gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · FYA Gown, Surgical
Cleared on Feb 21, 2022 as substantially equivalent to K190950 (Medline Industries, Inc., 2019) after a 444-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Feb 21, 2022
- Review
- 444 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K020593 (2002). No later device cites it as a predicate yet.
- Root · 3 generations backK020593 Convertors SMS Polyolefin GownAllegiance Healthcare Corp. · 2002 · Recalled
- 2 generations backK170762 Cardinal Health Non-Reinforced Surgical GownCardinal Health200, LLC · 2017 · Recalled
- 1 generation backK190950 Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline…Medline Industries, Inc. · 2019 · Recalled
- This deviceK203548 EndoArmor™ + Surgical GownBoston Scientific Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K020593 | Convertors SMS Polyolefin Gown | Allegiance Healthcare Corp. | 2002 | 23 |
| −2 | K170762 | Cardinal Health Non-Reinforced Surgical Gown | Cardinal Health200, LLC | 2017 | 17 |
| −1 | K190950 | Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3… | Medline Industries, Inc. | 2019 | 2 |
| 0 (this device) | K203548 | EndoArmor™ + Surgical Gown | Boston Scientific Corporation | 2022 | — |
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 |
|---|---|---|---|
| * | K190950 | Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown…Summary page 4…Trade Name: Medline Level 3 Surgical Gown (Sirus Non-Reinforced) Manufacturer: Medline Industries, Inc. Clearance Number: K190950 Common Name: Surgical Gown Classification Name: Surgical Apparel Product Code: FYA Devi… | 2019 |
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 20 years and passes through 4 companies; a new generation was cleared every 2.6 years on median.
- 3 of the 3 ancestors have a recall of any class.
- 4 other devices also cite its predicate K190950.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
EndoArmor™+ Surgical Gowns are single-use personal protective equipment 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.
EndoArmor™+ Surgical Gowns meet the respective Level 3 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/K203548 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203548: EndoArmor™ + Surgical Gown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203548
Report an extraction error
Are you the manufacturer?
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