Kf-E Series of Hollow Fiber Dialyzers
FDA 510(k) K812353 · Medisystems Corp.
510(k) numberK812353
Submission
- Device name
- Kf-E Series of Hollow Fiber Dialyzers
- Applicant
- Medisystems Corp.
Mchenry, IL, US - Received
- August 19, 1981
- Decision date
- September 16, 1981
- 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 |
|---|---|---|
| K062953 | Medisystems Arterial-Venous Fistula Needle Set with Securement DeviceFIE · Traditional | 02/12/2007SE |
| K010279 | Medisystems Luer Access Injection SiteFPA · Traditional | 05/29/2001SE |
| K002372 | Access Alert GaugeKOC · Traditional | 10/25/2000SE |
| K994306 | ReversoKOC · Traditional | 03/20/2000SE |
| K990803 | Medisystems Buttonhole Needle SetsFIE · Traditional | 01/06/2000SE |
| K983076 | Medisystems Transducer ProtectorFIB · Traditional | 11/25/1998SE |
| K971860 | Medisystems Dialysis Priming SetsKOC · Traditional | 08/18/1997SE |
| K963668 | Medisystems Peritoneal Dialysis SetsKDJ · Traditional | 08/15/1997SE |
| K970536 | Medisystems Tranducer ProtectorFIB · Traditional | 05/12/1997SE |
| K953823 | Arterial Venous Blood Tubing SetFJK · Traditional | 09/23/1996SE |
Questions and answers
When was Kf-E Series of Hollow Fiber Dialyzers cleared by the FDA?
Kf-E Series of Hollow Fiber Dialyzers (K812353) received a 510(k) decision of Substantially Equivalent on September 16, 1981, 28 days after the submission was received.
What is the product code of K812353?
The FDA product code is FJI – Dialyzer, Capillary, Hollow Fiber, a Class II (moderate risk) device regulated under 21 CFR 876.5820.