DeVilbiss
Homecare Suction, North America with 800CC bottle with External Filter and Rechargeable Battery
5manufacturers in China registered for this device type
35catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Guangdong (2), Shanghai (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| Laerdal Medical (Suzhou) Co., Ltd. | 215009 Suzhou Jiangsu Province | Repacker / relabeller | 12 | |
| Vega Technologies Inc. | Dongguan | Guangdong | Repacker / relabeller | 7 |
| Foshan Care Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 3 |
Record
| Listed by | DeVilbiss Healthcare LLC., United States |
|---|---|
| FDA product code | JCX |
| Device type | Apparatus, Suction, Ward Use, Portable, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4780 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K982304 |
| Record published | 2016-09-14 |
| Record revised | 2026-07-28 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 158 °F |
| Distribution end date | 2026-07-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7314D-D | In distribution | |
| 7314P-D-EXF | In distribution | |
| 7325P-D-EXF | In distribution | |
| 7305P-D | In distribution | |
| 7305D-D-EXF | In distribution | |
| 7314P-D | In distribution | |
| 7305D-D | In distribution | |
| 7325D-D-EXF | In distribution | |
| 7310PR-D | In distribution | |
| 7305P-D-EXF | In distribution | |
| 7305D-G | Withdrawn | |
| 7310PD-S | Withdrawn | |
| 7305P-U | Withdrawn | |
| 7305P-I | Withdrawn | |
| 7305P-T | Withdrawn | |
| 7314P-AP | Withdrawn | |
| 7305D-D | Withdrawn | |
| 7310PD-DE | Withdrawn | |
| 7310PR-I | Withdrawn | |
| 7314D-NE | Withdrawn | |
| 7310PD-PS | Withdrawn | |
| 7305D-LA | Withdrawn | |
| 7314P-NE | Withdrawn | |
| 7305D-I | Withdrawn | |
| 7314D-LA | Withdrawn | |
| 7305P-G | Withdrawn | |
| 7314D-U | Withdrawn | |
| 7314D-AP | Withdrawn | |
| 7305P-F | Withdrawn | |
| 7305P–LA | Withdrawn | |
| 7314P-U | Withdrawn | |
| 7314D-D-EXF | Withdrawn | |
| 7310PR-S | Withdrawn | |
| 7314P-LA | Withdrawn | |
| 7314P-UR | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neptune | Stryker GmbH | 16 |
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | Zimmer Orthopaedic Surgical Products | 16 |
| IntelliCart™ | Zimmer Orthopaedic Surgical Products | 13 |
| Penumbra System | Penumbra Inc. | 8 |
| Schuco | Allied Medical LLC | 7 |
| Gomco | Allied Medical LLC | 7 |
| Roscoe Medical | Drive DeVilbiss Healthcare | 5 |
| Cliq Aspirator | Anest Iwata Sparmax Co., Ltd. | 5 |
| Drive | Drive DeVilbiss Healthcare | 4 |
| Truvic Generator | Taiwan Biomaterial Company, Ltd. | 4 |
| Phantom | Innovative Med, Inc. | 4 |
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | Stryker GmbH | 4 |
Showing 12 of 65. All products under Apparatus, Suction, Ward Use, Portable, Ac-Powered
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| DeVilbiss Healthcare LLC. | 510(k) number | 2016-05-23 | Class II | Component design/selection | A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation. | 48 units | 2017-05-30 |
| DeVilbiss Healthcare LLC. | 510(k) number | 2013-03-07 | Class II | Use error | End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter cartridge to fluid, thereby occluding the filter and rendering it unusable. | 112,849 | 2014-11-06 |
| DeVilbiss Healthcare LLC. | 510(k) number | 2008-10-27 | Not classified | Device Design | Improper suction: Regulator knob does not turn properly which can affect the suction level. | 78 units | 2012-09-25 |
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.