PlumeSafe® X5™
The PlumeSafe X5 filter captures surgical smoke and aerosols when used with the PlumeSafe X5 Smoke Management System. The separate evacuation unit draws smoke from an electrosurgical or…
The PlumeSafe X5 filter captures surgical smoke and aerosols when used with the PlumeSafe X5 Smoke Management System. The separate evacuation unit draws smoke from an electrosurgical or laser procedure through connected accessories and into the filter.
The reusable filter is a self contained, enclosed assembly designed to limit exposure to its contents during changes. It connects to accessories such as smoke pencils, adapters, fluid traps and tubing sets.
Listed Item
PlumeSafe® X5™ Filter, With 7/8” (22 mm), 3/8” (9.5 mm), 7/8” (22 mm) Ports
Five Filtration Stages
The filter combines a gross particulate prefilter, an ultralow penetration air stage, coconut based carbon, impregnated alumina and carbon dust capture media. Filter configurations accommodate different connection sizes, and the filtered air returns to the surrounding environment.
Who Else Makes It
Concentrated in Zhejiang (1), Shandong (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Shuyou Surgical Instrument Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| BIO Protech Yantai Inc | Yantai | Shandong | Manufacturer | 12 |
| Wickimed (Huizhou) Medical Equipment Manufacturing Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 3 |
Record
| Listed by | ConMed Corporation, United States |
|---|---|
| FDA product code | FYD |
| Device type | Apparatus, Exhaust, Surgical |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5070 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K240127 |
| Record published | 2024-08-12 |
| Record revised | 2026-07-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment humidity 0 to 85 % RH; Storage environment temperature -29 to 149 °F; Storage environment temperature -34 to 65 °C |
| Distribution end date | 2026-07-22 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| PX5-120NF | In distribution | ||
| PX5-1354-22 | 4 | In distribution | |
| PX5-1354 | In distribution | ||
| PX5-135 | In distribution | ||
| PX5-135-22 | In distribution | ||
| PX5-120 | In distribution | ||
| PX5-1354-22 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Microtek | Microtek Medical LLC | 57 |
| Surgimedics® | Coastal Life Technologies, Inc. | 23 |
| Virosafe | ConMed Corporation | 22 |
| Buffalo Filter | Buffalo Filter Co., Inc. | 22 |
| ACU-Evac | Acuderm, Inc. | 21 |
| Neptune | Stryker GmbH | 14 |
| RapidVac | Covidien LP | 12 |
| Megadyne | Megadyne Medical Products, Inc. | 12 |
| Geiger Smoke Evacuator Filter | Dermatologic LAB AND Supply, Inc. | 12 |
| Apparatus, Exhaust, Surgical | Stryker GmbH | 11 |
| Apparatus, Exhaust, Surgical | ConMed Corporation | 10 |
| Conmed Buffalo Filter | ConMed Corporation | 10 |
Showing 12 of 142. All products under Apparatus, Exhaust, Surgical
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240127 | 2024-08-05 |
| K091139 | 2009-05-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.