Reverse Osmosis Water Purification System
510(k) K871242
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK871242 | Date16 Mar 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FIP
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5665
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
This device is a Water Purification Subsystem (FDA classification: Class II) designed to remove contaminants from water via reverse osmosis. It employs a semi-permeable membrane to filter out dissolved salts, ions, and suspended solids under pressure, producing purified water for medical, industrial, or commercial applications. The system is intended for use in settings requiring high-purity water, such as dialysis or laboratory environments.
The Reverse Osmosis Water Purification System is supplied as a standalone unit for on-site installation, requiring connection to a water source and electrical power. It is classified as a reusable device and is not sterile by design, as it is intended for non-clinical water purification rather than direct patient contact. The system operates under FDA 510(k) clearance (K871242) and adheres to regulatory standards outlined in 21 CFR 876.5665. No MRI safety or single-use specifications are applicable.
Questions
AI-generated answers, 20 Sep 2026
What types of environments is this reverse osmosis water purification system designed for, and how does it differ from systems meant for direct patient use?
This system is specifically engineered for settings requiring high-purity water, such as dialysis centers or laboratories, where purified water is needed for non-patient-contact applications like equipment rinsing, cleaning, or process water. Unlike devices intended for direct patient use (e.g., sterile water for injections), it is not sterile by design and is not meant for direct patient contact. It is classified as a reusable, non-sterile subsystem under FDA 510(k) clearance (K871242), adhering to regulatory standards for water purification (21 CFR 876.5665).
Is this system portable, or is it meant for permanent installation, and what connections does it require?
The system is supplied as a standalone unit for on-site installation, not portable. It requires connection to a water source (e.g., municipal or well water) and electrical power to operate. It is designed for fixed placement in environments like medical or industrial facilities where high-purity water is needed for non-clinical purposes.
How is the system maintained, and is it intended for single-use or repeated use over time?
The system is classified as reusable, meaning it is designed for repeated use over time with proper maintenance. Since it is not sterile by design and is intended for non-patient-contact applications, maintenance would involve routine cleaning, membrane replacement (as needed), and adherence to manufacturer guidelines to ensure consistent performance and contaminant removal. Sterilization is not applicable.
What regulatory pathway was followed for FDA clearance, and which advisory committee was involved?
The system received FDA 510(k) clearance (K871242) under a traditional review pathway, determined to be *substantially equivalent* to a predicate device. The Gastroenterology and Urology (GU) Advisory Committee was involved in the review process, though the committee’s role was administrative (e.g., classification or filing) rather than indicating a clinical indication. The system falls under FDA classification Class II and regulatory category FIP (Water Purification Subsystem).
Are there multiple models or sizes available, or is this a single-unit system?
The provided data lists multiple registration numbers (e.g., 3005162618, 3017974963, etc.), which typically correspond to different models or variations of the system. While the core function (reverse osmosis purification) remains consistent, these identifiers suggest the manufacturer offers variations in capacity, flow rate, or configuration to suit different facility needs. For exact specifications (e.g., flow rates, membrane sizes), consulting the manufacturer’s documentation or contacting Medro Systems directly would be necessary.