Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K163609 FDA 510(k)
- FDA Product Code
- NHV FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5665 FDA 510(k)
- Regulation Number
- 876.5665 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pall QPoint Water Filter Capsule is a disposable, point-of-use water filtration system designed for general medical use. It provides 0.2-micron sterilizing-grade filtration, ensuring water purity for applications requiring high-quality, filtered water, such as healthcare settings. The device is categorized under water purification systems and is intended for use in shower and faucet installations.
The capsules are single-use, non-sterile devices supplied in sterile packaging for immediate use. They are compatible with the QPoint docking station and offer up to 62 days of filtered water, depending on water quality. The capsules are classified as Class II medical devices under FDA regulations and have received 510(k) clearance. Storage should follow manufacturer guidelines to maintain functionality and integrity.
Frequently asked questions
Are the Pall QPoint Water Filter Capsules designed for reuse, or are they intended for single-use only?
The Pall QPoint Water Filter Capsules are explicitly designed for single-use only. They are supplied in sterile packaging for immediate use, ensuring no risk of contamination from repeated exposure to water. After use, the capsule should be discarded to maintain water purity and device integrity.
What types of installations can the Pall QPoint Water Filter Capsules be used in, and how do I know which one to choose?
The capsules are available in two configurations: one for shower installations and another for faucet installations. The correct choice depends on where you need filtered water—select the Shower capsule for showerheads or the Faucet capsule for kitchen or bathroom taps. Both are compatible with the QPoint docking station.
How long can I expect the Pall QPoint Water Filter Capsule to last before needing replacement, and does that depend on anything?
The capsules provide up to 62 days of filtered water, though the exact duration depends on your water quality. Hard water or higher usage rates may reduce the lifespan. The manufacturer recommends monitoring usage and replacing the capsule when the flow rate or filtration efficiency declines, as indicated by the device’s performance.
Are the Pall QPoint Water Filter Capsules sterile, and if not, how should they be handled to prevent contamination?
The capsules themselves are non-sterile, but they are supplied in sterile packaging for immediate use. To prevent contamination, avoid opening the packaging until ready to install the capsule. Once installed, the filtered water should meet the device’s sterilizing-grade (0.2-micron) filtration standards, but the capsule housing itself is not sterile post-installation.
What storage instructions should I follow to ensure the capsules remain effective until use?
The capsules should be stored according to the manufacturer’s guidelines to maintain functionality and integrity. This typically includes keeping them in their original, sealed packaging in a cool, dry place away from direct sunlight or extreme temperatures. Avoid exposure to moisture or contaminants, as this could compromise the filter’s performance or sterility of the packaging.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: QPoint™ Shower Water Filter | International Medical Products, Shower water filters for healthcare - Cytiva, PDF QPoint Shower Water Filter - GLOBALCUBE
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163609 | Class II | Active |
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Manufacturer
- Manufacturer
- Pall International SARL
Sources (1)
- FDA 510(k) K163609 24 fields · synced Sep 19, 2026