510(k) · Cleared
ClearedJoykey Surgical Gowns (Sterile)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Joykey Industryial, Ltd. · FYA Gown, Surgical
Cleared on Mar 14, 2007 as substantially equivalent to K012186 (Master & Frank Ent. Co., Ltd., 2001) after a 202-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Mar 14, 2007
- Review
- 202 days
- Class
- Class II
- Product code
- FYA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K964142 (1997). No later device cites it as a predicate yet.
- Root · 2 generations backK964142 Medline Disposable Surgical Drapes and GownsMedline Industries, Inc. · 1997 · Recalled
- 1 generation backK012186 Master & Frank Surgical Gowns (Sterile)Master & Frank Ent. Co., Ltd. · 2001
- This deviceK062479 Joykey Surgical Gowns (Sterile)Joykey Industryial, Ltd. · 2007
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K012186 | Master & Frank Surgical Gowns (Sterile)Summary page 1…Sterile Surgical Gowns Classification name: GOWN, SURGICAL 3. Classification: Class II 4. Predicate Device: Master & Frank Surgical Gowns (Sterile) (K012186) marketed by Master & Frank Enterprise Co., Ltd. 5. Device Description: JOYKEY Surgical Gowns (St… | 2001 |
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 10 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K012186.
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?
JOYKEY Surgical Gowns (Sterile) are single use article of surgical apparel worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062479 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062479: Joykey Surgical Gowns (Sterile).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062479
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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