RM3 Renal Preservation System
FDA 510(k) K042224 · Waters Instruments, Inc.
510(k) numberK042224
Submission
- Device name
- RM3 Renal Preservation System
- Applicant
- Waters Instruments, Inc.
Plymouth, MN, US - Received
- August 17, 2004
- Decision date
- October 22, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KDN – System, Perfusion, Kidney
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5880
- Specialty
- Gastroenterology, Urology
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| K260456 | VI°Port Liver Preservation SystemKDN · Traditional | Traferox Technologies, Inc. | 06/01/2026SE |
| K254305 | BAROguard Donor Lung Preservation SystemKDN · Special | Paragonix Technologies, Inc. | 01/30/2026SE |
| K243618 | EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)KDN · Traditional | Bridge TO Life | 06/17/2025SE |
| K243870 | X°Port Lung Preservation System; X°Port Lung Preservation SolutionKDN · Traditional | Traferox Technologies, Inc. | 05/01/2025SE |
| K243998 | DCX Disposable Cassette (DCX)KDN · Traditional | Institut Geroges Lopez | 04/25/2025SE |
| K243384 | Belzer UW® Cold Storage Solution (BTLBUW-001)KDN · Traditional | Bridge TO Life | 03/31/2025SE |
| K243840 | Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)KDN · Traditional | Bridge TO Life | 03/26/2025SE |
| K240650 | LungProtectKDN · Traditional | Traferox Technologies, Inc. | 11/26/2024SE |
| K234060 | KIDNEYvault Portable Renal Perfusion SystemKDN · Traditional | Paragonix Technologies | 10/23/2024SE |
More from Paragonix Technologies
| 510(k) | Device | Decision |
|---|---|---|
| K053169 | RM3 Renal Preservation SystemKDK · Special | 01/17/2006SE |
| K971571 | RM3 Renal Preservation System--Control UnitKDN · Traditional | 07/29/1997SE |
| K921519 | OXICOM-2100DQA · Traditional | 10/23/1992SE |
| K911207 | OxicomplusDQA · Traditional | 08/26/1991SE |
| K863210 | VELCOM-100DPW · Traditional | 11/26/1986SE |
| K862161 | OSC-80 OximeterDQA · Traditional | 08/18/1986SE |
| K852909 | MVP - 6000BZC · Traditional | 11/14/1985SE |
| K834408 | TX-2 Thermal Dilution Cardiac OutputDXG · Traditional | 08/23/1984SE |
| K841876 | Polyurethane Thermal Dilution CathetDYG · Traditional | 07/13/1984SE |
| K813585 | Waters Ileostomy ValveKNT · Traditional | 04/09/1982SE |
Questions and answers
When was RM3 Renal Preservation System cleared by the FDA?
RM3 Renal Preservation System (K042224) received a 510(k) decision of Substantially Equivalent on October 22, 2004, 66 days after the submission was received.
What is the product code of K042224?
The FDA product code is KDN – System, Perfusion, Kidney, a Class II (moderate risk) device regulated under 21 CFR 876.5880.