Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart F — Therapeutic Devices](/submissions/GU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 876.5820](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5820) → FJI — Dialyzer, Capillary, Hollow Fiber # FJI · Dialyzer, Capillary, Hollow Fiber _Gastroenterology, Urology · 21 CFR 876.5820 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJI ## Overview - **Product Code:** FJI - **Device Name:** Dialyzer, Capillary, Hollow Fiber - **Regulation:** [21 CFR 876.5820](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/876.5820) - **Device Class:** 2 - **Review Panel:** [Gastroenterology, Urology](/submissions/GU) - **Life-sustaining:** yes ## Identification A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray. ## Classification Rationale (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. ## Recent Cleared Devices (20 of 131) Showing 20 most recent of 131 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K190459](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJI/K190459.md) | Hemoflow F3 and F4 Dialyzers | Fresenius Medical Care Renal Therapies Group, LLC | Aug 23, 2019 | SESE | | [K122952](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJI/K122952.md) | NIPRO PUREFLUX-L HEMODIALYZER | Nipro Medical Corporation | Dec 4, 2013 | SESE | | [K043342](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJI/K043342.md) | POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR | Gambro Renal Products | May 27, 2005 | SESE | | [K010366](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJI/K010366.md) | DISPOSABLE STORAGE CAP | Molded Products, Inc. | Nov 28, 2001 | SESE | | [K011148](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJI/K011148.md) | ULTRACONCENTRATOR SYSTEM | Interpore Cross Intl. | Jun 13, 2001 | SESE | | [K002761](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJI/K002761.md) | FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS | Fresenius Medical Care North America | Dec 4, 2000 | SESE | | [K991908](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJI/K991908.md) | IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS | Idemsa | Apr 17, 2000 | SESE | | [K992594](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJI/K992594.md) | A-15 HEMODIALYZER | Althin Medical AB | Sep 24, 1999 | SESE | | [K992565](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJI/K992565.md) | A-18 HEMODIALYZER | Althin Medical AB | Sep 23, 1999 | SESE | | [K991512](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJI/K991512.md) | ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X | Asahi Medical Co., Ltd. | Jul 29, 1999 | SESE | | [K990159](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJI/K990159.md) | DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111 | Dynamic Technology Corp. | Apr 19, 1999 | SESE | | [K982337](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJI/K982337.md) | CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER | Haidylena Medical Egypt | Dec 29, 1998 | SESE | | [K981253](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJI/K981253.md) | ULTRACON ULTRAFILTRATOR | Interpore Intl. | Dec 11, 1998 | SESE | | [K980658](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJI/K980658.md) | PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234 | Baxter Healthcare Corp | May 19, 1998 | SESE | | [K971710](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJI/K971710.md) | ULTRACON ULTRAFILTRATOR | Quantic Biomedical, Inc. | Feb 27, 1998 | SESE | | [K973291](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJI/K973291.md) | DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES | Dynamic Technology Corp. | Dec 19, 1997 | SESE | | [K970708](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJI/K970708.md) | CLIRANS T-SERIES HOLLOW FIBER DIALYZERS | Terumo Medical Corp. | Dec 19, 1997 | SESE | | [K963933](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJI/K963933.md) | PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER | Baxter Healthcare Corp | Nov 24, 1997 | SESE | | [K962309](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJI/K962309.md) | ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS | Althin Medical AB an Affiliate of Baxter Intl | Dec 27, 1996 | SESE | | [K961039](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJI/K961039.md) | BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL | Dayspring Medical, Inc. | Sep 12, 1996 | SESE | ## Top Applicants - Gambro, Inc. — 10 clearances - Baxter Healthcare Corp — 9 clearances - National Medical Care, Medical Products Div., Inc. — 9 clearances - Cordis Corp. — 8 clearances - Erika, Inc. — 8 clearances --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJI](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/FJI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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