K222727 is an FDA 510(k) clearance for the i3 ONE (203100-S). This device is classified as a System, Water Purification, General Medical Use (Class II - Special Controls, product code NHV).
Submitted by I3 Membrane GmbH (Radeberg, DE). The FDA issued a Cleared decision on June 2, 2023, 267 days after receiving the submission on September 8, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5665. The Device Is A Portable Water Treatment System Which Features Components And Technology Similar To Water Treatment Systems Previously Cleared For Hemodialysis. The Difference Lies With The Intended Use, As The Proposed Device Is Not Intended For Use In Hemodialysis Applications, For Which A Product Code Currently Exists. Instead, The Proposed Device Is Intended For Use To Purify Water For General Purposes, Including Washing Of Surgeons Hands, Surgical Instruments, And Wound Cleansing..
| 510(k) Number | K222727 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2022 |
| Decision Date | June 02, 2023 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NHV - System, Water Purification, General Medical Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5665 |
| Definition | The Device Is A Portable Water Treatment System Which Features Components And Technology Similar To Water Treatment Systems Previously Cleared For Hemodialysis. The Difference Lies With The Intended Use, As The Proposed Device Is Not Intended For Use In Hemodialysis Applications, For Which A Product Code Currently Exists. Instead, The Proposed Device Is Intended For Use To Purify Water For General Purposes, Including Washing Of Surgeons Hands, Surgical Instruments, And Wound Cleansing. |