510(k) · Cleared
ClearedSri/Surgical Express SP Reusable Surgical Gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sri/Surgical Express, Inc. · FYA Gown, Surgical
Cleared on Nov 18, 2002 as substantially equivalent to K920405 (Amsco Sterile Recoveries, Inc., 1992) after a 20-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Nov 18, 2002
- Review
- 20 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920405 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK920405 Sterile Surgeon's GownAmsco Sterile Recoveries, Inc. · 1992
- This deviceK023635 Sri/Surgical Express SP Reusable Surgical GownSri/Surgical Express, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920405 | Sterile Surgeon's Gown | Amsco Sterile Recoveries, Inc. | 1992 | — |
| 0 (this device) | K023635 | Sri/Surgical Express SP Reusable Surgical Gown | Sri/Surgical Express, Inc. | 2002 | — |
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 |
|---|---|---|---|
| * | K920405 | Sterile Surgeon's GownSummary page 1…Zones. The gown in this submission is substantially equivalent to the Sterile Recoveries, Inc. surgical gown as cleared under K920405. The results of safety and efficacy performance testing of the SRI/Surgical Express, Inc. reusable surgical… | 1992 |
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?
- Its one ancestor has no recall.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Surgical gowns are devices that are intended to be worn by health care personnel during surgical or other medical procedures to protect both the surgical patient and the wearer from transfer of microorganisms, body fluids, and particulate material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023635 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023635: Sri/Surgical Express SP Reusable 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/K023635
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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