510(k) · Cleared
ClearedVESTEX Apparel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vestagen Protective Technologies, Inc. · QBW Surgical Apparel With Material Claims
Cleared on May 18, 2018 as substantially equivalent to K891212 (Pro-Safe Professional Linens, Inc., 1989) after a 113-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- May 18, 2018
- Review
- 113 days
- Class
- Class II
- Product code
- QBW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K891212 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK891212 Aprons, Scrubs Slacks & Tops, Patient DrapePro-Safe Professional Linens, Inc. · 1989
- This deviceK180217 VESTEX ApparelVestagen Protective Technologies, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891212 | Aprons, Scrubs Slacks & Tops, Patient Drape | Pro-Safe Professional Linens, Inc. | 1989 | — |
| 0 (this device) | K180217 | VESTEX Apparel | Vestagen Protective Technologies, Inc. | 2018 | — |
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 QBW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K891212 | Aprons, Scrubs Slacks & Tops, Patient DrapeSummary page 4…Suit, Surgical Product Code / Regulation QBW / 21 CFR § 878.4040 Class II Classification Predicate Devices K891212 (Aprons, Scrub Slacks & Tops, Patient Drape) – Pro-Safe Professional Linens, Inc.… | 1989 |
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 QBW devicesQBW Surgical Apparel With Material Claims: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QBW
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · QBW
Too few QBW 510(k)s in any year since 2007 to give a median.
Recalls per year · QBW
No recall names QBW since 2007.
Adverse event reports per year · QBW
No MAUDE report names QBW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
VESTEX® Apparel (“VESTEX”), scrub tops, pants, skirts, and lab coats are apparel that provides fluid repellency and reduces the retention of Methicillin Resistant Staphylococcus aureus (MRSA) on the surface (outer layer) of the apparel.
The ability of VESTEX to reduce the retention of MRSA on the fabric surface has not been shown to correlate with the reduction of infections. Clinical studies to evaluate reduction in infection have not been performed for this device.
VESTEX Apparel is not intended to replace personal protective equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180217 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180217: VESTEX Apparel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180217
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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