Renak-E & Renek-A Series Hollow Fiber Dialyzers
FDA 510(k) K883748 · Kawasumi Laboratories Co., Ltd.
510(k) numberK883748
Submission
- Device name
- Renak-E & Renek-A Series Hollow Fiber Dialyzers
- Applicant
- Kawasumi Laboratories Co., Ltd.
Tokyo, JP - Received
- September 1, 1988
- Decision date
- January 31, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FJI – Dialyzer, Capillary, Hollow Fiber
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code FJI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K190459 | Hemoflow F3 and F4 DialyzersFJI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 08/23/2019SE |
| K122952 | Nipro Pureflux-L HemodialyzerFJI · Traditional | Nipro Medical Corporation | 12/04/2013SE |
| K043342 | Polyflux Family Hemodialyzer/Filter Labeled for Single and Multiple Use, Models 14L…FJI · Traditional | Gambro Renal Products | 05/27/2005SE |
| K010366 | Disposable Storage CapFJI · Abbreviated | Molded Products, Inc. | 11/28/2001SE |
| K011148 | Ultraconcentrator SystemFJI · Special | Interpore Cross Intl. | 06/13/2001SE |
| K002761 | Fresnius Hemoflow F7NR, F50NR, F70NR HemodialyzersFJI · Traditional | Fresenius Medical Care North America | 12/04/2000SE |
| K991908 | Idemsa Hemophan Hollow Fiber DialyzersFJI · Traditional | Idemsa | 04/17/2000SE |
| K992594 | A-15 HemodialyzerFJI · Traditional | Althin Medical AB | 09/24/1999SE |
| K992565 | A-18 HemodialyzerFJI · Traditional | Althin Medical AB | 09/23/1999SE |
| K991512 | Asahi Am-R-Series Dialyzers (Modified), Model Am-Nr-XFJI · Traditional | Asahi Medical Co., Ltd. | 07/29/1999SE |
More from Asahi Medical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K190485 | Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH)JKA · Traditional | 07/08/2019SE |
| K190233 | K-Shield Advantage Port Access Infusion Set (PAIS)FPA · Special | 05/02/2019SE |
| K172957 | Kawasumi Laboratories Blood Drawing Kit (BDK) SystemKSB · Traditional | 09/28/2018SE |
| K123344 | K-Shield Advantage Port Access Infusion Set (Pais)FPA · Traditional | 03/07/2013SE |
| K100720 | K-Shield Port Access Infusion Set with High Pressure TubingFPA · Traditional | 11/18/2010SE |
| K102994 | K-Shield Arterial Venous Fistula Set with Antineedle Stick ProtectorFMI · Special | 11/03/2010SE |
| K073257 | Kawasumi Laboratories Large Wing Sets with Antineedle Stick ProtectorFMI · Traditional | 01/25/2008SE |
| K061197 | Kawasumi Laboratories Empty Solution ContainerKPE · Traditional | 06/30/2006SE |
| K060580 | K-Shield Port Access Infusion SetFPA · Traditional | 06/06/2006SE |
| K023917 | Winged Needle Sets with an Antineedle Stick ProtectorFPA · Traditional | 02/26/2003SE |
Questions and answers
When was Renak-E & Renek-A Series Hollow Fiber Dialyzers cleared by the FDA?
Renak-E & Renek-A Series Hollow Fiber Dialyzers (K883748) received a 510(k) decision of Substantially Equivalent on January 31, 1989, 152 days after the submission was received.
What is the product code of K883748?
The FDA product code is FJI – Dialyzer, Capillary, Hollow Fiber, a Class II (moderate risk) device regulated under 21 CFR 876.5820.