i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)
FDA 510(k) K222727 · I3 Membrane GmbH
Submission
- Device name
- i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S)
- Applicant
- I3 Membrane GmbH
Radeberg, DE - Received
- September 8, 2022
- Decision date
- June 2, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NHV – System, Water Purification, General Medical Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5665
- Specialty
- Gastroenterology, Urology
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…
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| K182164 | Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU…NHV · Special | Ecolab, Inc. | 03/29/2019SE |
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| K163609 | Pall QPoint Water Filter Capsule (Shower), Pall QPoint Water Filter Capsule (Faucet)NHV · Traditional | Pall International Sarl | 06/01/2017SE |
| K161467 | HydraGuard 10 UltraFilterNHV · Special | Nephros, Inc. | 12/22/2016SE |
| K153784 | Nosogard FiltersNHV · Traditional | Evoqua Water Technologies, LLC | 10/21/2016SE |
| K153434 | Pall-Aquasafe Water FilterNHV · Traditional | Pall International Sarl | 06/10/2016SE |
| K153084 | Nephros S100NHV · Traditional | Nephros, Inc. | 04/08/2016SE |
| K141731 | Nephros Dsu-H, Nephros Ssu-HNHV · Traditional | Nephros, Inc. | 10/24/2014SE |
Questions and answers
When was i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) cleared by the FDA?
i3 ONE (203100-S);i3 TWO connect (203200-S);i3 TWO direct (203300-S) (K222727) received a 510(k) decision of Substantially Equivalent on June 2, 2023, 267 days after the submission was received.
What is the product code of K222727?
The FDA product code is NHV – System, Water Purification, General Medical Use, a Class II (moderate risk) device regulated under 21 CFR 876.5665.