510(k) · Cleared
ClearedWelmed, Inc. Surgical Gowns
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welmed, Inc. · FYA Gown, Surgical
Cleared on May 24, 2007 as substantially equivalent to K052550 (Intl. Medsurg Connection, Inc., 2005) after a 100-day review. Its family tree reaches back 2 generations to 2003. 2 later devices descend from it.
- Decided
- May 24, 2007
- Review
- 100 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K030364 (2003). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK030364 Deroyal Gowns, Sterile, Non-SterileDeroyal Industries, Inc. · 2003
- 1 generation backK052550 Imc Surgical GownsIntl. Medsurg Connection, Inc. · 2005
- This deviceK070431 Welmed, Inc. Surgical GownsWelmed, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK102692 SMS Gowns (Reinforced and Reinforced with Guider), Spunlace Gowns…Hangzhou Jincheng Medical Supplier Manufacture Co. · 2011
- Descendant · cites it directly · 0 of its ownK082479 Sklar Surgical GownSklar Corp. · 2009
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 |
|---|---|---|---|---|---|
| −2 | K030364 | Deroyal Gowns, Sterile, Non-Sterile | Deroyal Industries, Inc. | 2003 | — |
| −1 | K052550 | Imc Surgical Gowns | Intl. Medsurg Connection, Inc. | 2005 | — |
| 0 (this device) | K070431 | Welmed, Inc. Surgical Gowns | Welmed, Inc. | 2007 | — |
| +1 | K102692 | SMS Gowns (Reinforced and Reinforced with Guider), Spunlace Gowns (Regular… | Hangzhou Jincheng Medical Supplier Manufacture Co. | 2011 | — |
| +1 | K082479 | Sklar Surgical Gown | Sklar Corp. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K052550 | Imc Surgical GownsSummary page 2…Number Welmed Surgical IMC Surgical International Medsurg K052550 Gowns Gowns Connections, Inc. 5.0 Intended Use: Disposable gowns… | 2005 |
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)
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 4 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K102692 (Hangzhou Jincheng Medical Supplier Manufacture Co., 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K052550.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Disposable gowns are used in the OR as a protective covering, for operating room staff, from the transfer of body fluids and particulates.
Gowns provided as sterile and non-sterile.
Non-sterile surgical gowns are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Gowns are to be sold directly to users after EtO sterilization validation to ISO 11135.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070431: Welmed, Inc. Surgical Gowns.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070431
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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