510(k) · Cleared
ClearedMaxima Surgical Gown
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elevate Textiles · FYA Gown, Surgical
Cleared on Mar 11, 2022 as substantially equivalent to K150598 (Medline Industries, Inc., 2016) after a 659-day review. Its family tree reaches back 1 generation to 2016.
- Decided
- Mar 11, 2022
- Review
- 659 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K150598 (2016). No later device cites it as a predicate yet.
- Root · 1 generation backK150598 Blockade Surgical GownMedline Industries, Inc. · 2016
- This deviceK201351 Maxima Surgical GownElevate Textiles · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K150598 | Blockade Surgical Gown | Medline Industries, Inc. | 2016 | — |
| 0 (this device) | K201351 | Maxima Surgical Gown | Elevate Textiles | 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 |
|---|---|---|---|
| * | K150598 | Blockade Surgical GownSummary page 4…: Sterile Surgical Gown Classification Name: Surgical Gown, Class 2 Predicate Device - Maxima® Surgical Gown claims substantial equivalence to: K150598 Blockade Surgical Gown manufactured by Medline Industries, Inc Device Description The Maxima® Surgical Gown is a reusable woven… | 2016 |
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. 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?
The reusable Maxima Surgical Gown is intended to be used by operating room personnel during surgical procedures to
help protect both the patient and the health care worker from transfer of micro-organisms, body fluids, and particulate
material.
The reusable Maxima Surgical Gown is provided non-sterile. Sterilization parameters are as follows:
* Prevac Steam Sterilization - 135 0 C/274 0 F (temperature) / 3 minutes (exposure time) / 20 minutes (dry time)
Elevate Textiles Item Numbers / gown color / liquid barrier protection / gown size
MAXAL3S / Royal Blue B103 / AAMI Level 3 / Small
MAXAL3M / Royal Blue B103 / AAMI Level 3 / Medium
MAXAL3L / Royal Blue B103 / AAMI Level 3 / Large
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201351: Maxima Surgical Gown.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201351
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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