510(k) · Cleared
ClearedPromedical Surgical Gown, Models 18-301, 18-401 and 18-501
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promedical Products Co., Ltd. · FYA Gown, Surgical
Cleared on May 27, 2009 after a 41-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 10 later devices descend from it.
- Decided
- May 27, 2009
- Review
- 41 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK091097 Promedical Surgical Gown, Models 18-301, 18-401 and 18-501Promedical Products Co., Ltd. · 2009
- Descendant · cites it directly · 9 of its ownK093115 Kimberly-Clark KC100 Surgical Gown, Model KC100Kimberly-Clark Corp. · 2010
- Descendant · 2 generations on · 8 of its ownK102652 Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns…Gri Medical & Electronic Technology Co., Ltd. · 2011
- Descendant · 3 generations on · 7 of its ownK121152 Surgical Gown, SMSJiangsu Guangda Medical Material, Co., Ltd. · 2012
- Descendant · 4 generations on · 3 of its ownK212869 Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd. · 2021
- Descendant · 3 generations on · 1 of its ownK141467 Surgical GownXuchang Zhengde Environstar Medical Products Co.,L · 2015
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K093115Kimberly-Clark KC100 Surgical Gown, Model KC100Kimberly-Clark Corp. · 2010 · cites it directly9descendants
- K102652Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric Reinforced…Gri Medical & Electronic Technology Co., Ltd. · 2011 · 2 generations on8descendants
- K121152Surgical Gown, SMSJiangsu Guangda Medical Material, Co., Ltd. · 2012 · 3 generations on7descendants
- K212869Disposable Surgical Gown, Disposable Reinforced Surgical GownFugou County Shenxiang Manufacturing Co., Ltd. · 2021 · 4 generations on3descendants
- K141467Surgical GownXuchang Zhengde Environstar Medical Products Co.,L · 2015 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091097 | Promedical Surgical Gown, Models 18-301, 18-401 and 18-501 | Promedical Products Co., Ltd. | 2009 | — |
| +1 | K093115 | Kimberly-Clark KC100 Surgical Gown, Model KC100 | Kimberly-Clark Corp. | 2010 | — |
| +2 | K102652 | Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric… | Gri Medical & Electronic Technology Co., Ltd. | 2011 | — |
| +3 | K121152 | Surgical Gown, SMS | Jiangsu Guangda Medical Material, Co., Ltd. | 2012 | — |
| +4 | K212869 | Disposable Surgical Gown, Disposable Reinforced Surgical Gown | Fugou County Shenxiang Manufacturing Co., Ltd. | 2021 | — |
| +3 | K141467 | Surgical Gown | Xuchang Zhengde Environstar Medical Products Co.,L | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093115 | Kimberly-Clark KC100 Surgical Gown, Model KC100 | 2010 | 9 |
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?
- Of its descendants, K093115 (Kimberly-Clark Corp., 2010) has gone furthest, with 9 descendants of its own.
How does its category compare?
All FYA devicesFYA Gown, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 | — |
https://510kreport.com/device/K091097 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091097: Promedical Surgical Gown, Models 18-301, 18-401 and 18-501.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091097
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026