Asahi Kasei Medical MT Corp. Oita Works
Oita-Shi, JP
Asahi Kasei Medical MT Corp. Oita Works appears in FDA device records in Oita-Shi, JP. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 11 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Asahi Kasei Medical MT Corp. Oita Works carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Asahi Medical Co., Ltd.510(k), recall
510(k) clearance history
FDA records hold 16 510(k) clearances for Asahi Kasei Medical MT Corp. Oita Works between 1983 and 2004. The busiest year on record is 1989, with 3. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1985 | 2 |
| 1989 | 3 |
| 1990 | 3 |
| 1992 | 1 |
| 1997 | 1 |
| 1999 | 2 |
| 2000 | 1 |
| 2002 | 1 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K041726 | HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX | KDI | Substantially Equivalent | |
| K013418 | AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY | KDI | Substantially Equivalent | |
| K001250 | APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) | KDI | Substantially Equivalent | |
| K991512 | ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X | FJI | Substantially Equivalent | |
| K983720 | ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO- | MSE | Substantially Equivalent | |
| K970650 | ASAHI AM-R SERIES DIALYZERS | MSE | Substantially Equivalent | |
| K914020 | MODIFIED ASAHI PAN-SERIES HEMOFILTERS | KDI | Substantially Equivalent | |
| K901887 | MODIFIED SEPACELL R-SERIES BLOOD FILTERS | CAK | Substantially Equivalent | |
| K896976 | MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS | CAK | Substantially Equivalent | |
| K896664 | MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT | CAK | Substantially Equivalent | |
| K892375 | MODIFIED AM-SERIES DIALYZERS | FJI | Substantially Equivalent | |
| K892374 | NEW AM-SERIES DIALYZERS | FJI | Substantially Equivalent | |
| K885017 | HEMOSORBA CH-500, CH-350 AND CH-180 | FLD | Substantially Equivalent | |
| K854575 | MODIFIED AM-SERIES DIALYZERS | FJI | Substantially Equivalent | |
| K844663 | ASAHI NEW PAN-SERIES HEMOFILTERS | KDI | Substantially Equivalent | |
| K833150 | ASAHI HOLLOW FIBER KIDNEYS, EXCEL | KOC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8010002 | 3002806407 | Asahi Kasei Medical MT Corp. Oita Works | 2111-2 OAZA SATO, OITA-SHI 870-0396 JP | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KOCAccessories, Blood Circuit, Hemodialysis
- PBNApheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients
- FLDApparatus, Hemoperfusion, Sorbent
- FJIDialyzer, Capillary, Hollow Fiber
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- MSEHemodialyzer, Re-Use, Low Flux
- MMYLipoprotein, Low Density, Removal
- CAKMicrofilter, Blood Transfusion
- MDPSeparator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0175-2007 | Asahi AM-R Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of cuprammonium rayon housed within a plastic casing of styrene butadiene block polymer, sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Model AM-NR-65U - 1.3 m2 surface area, Model AM-NR-75U - 1.5 m2 surface area and Model AM-NR-100U - 2.0 m2 surface area | There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possibly damaging the dialyzer nozzle. | Terminated | ||
| Z-0174-2007 | Asahi AM-BIO D Series Hollow Fiber Dialyzers; a dry model single or multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Model AM-BIO-75D - 1.5 m2 surface area and Model AM-BIO-100D - 2.0 m2 surface area | There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possibly damaging the dialyzer nozzle. | Terminated | ||
| Z-0173-2007 | Asahi AM-BIO Series Hollow Fiber Dialyzers; a wet model single or multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Model AM-BIO-65 - 1.3 m2 surface area, Model AM-BIO-75 - 1.5 m2 surface area and Model AM-BIO-100 - 2.0 m2 surface area | There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possibly damaging the dialyzer nozzle. | Terminated | ||
| Z-0172-2007 | Asahi Rexeed Series Multiple-Use Hollow Fiber Dialyzers; a wet model multiple use dialyzer consisting of hollow fiber membranes of polysulfone/PVP housed within a plastic casing of styrene copolymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Model Rexeed-15R - 1.5 m2 surface area, Model Rexeed-18R - 1.8 m2 surface area, Model Rexeed-21R - 2.1 m2 surface area, Model Rexeed-25R - 2.5 m2 surface area | There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possibly damaging the dialyzer nozzle. | Terminated | ||
| Z-0171-2007 | Asahi APS Series Multiple-Use Hollow Fiber Dialyzers; a wet model multiple use dialyzer consisting of hollow fiber membranes of polysulfone housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Models APS-18R and APS-900S - 1.8 m2 surface area, Model APS-21R and APS-1050S - 2.1 m2 surface area | There have been reports of difficulty separating the Gambro Cartridge Blood Set from Asahi Reuse/Multiple Use Dialyzers at the end of treatment, possibly damaging the dialyzer nozzle. | Terminated | ||
| Z-0792-05 | Terumo Clirans Series EE Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (28 microns thick) of vitamin E coated copolymer cellulose housed within a polyurethane casing, filled at the factory with fluid to facilitate priming by the user, and sterilized by autoclaving before shipment; Terumo Corporation, Tokyo 151-0072, Japan; Terumo Medical Corporation, Somerset, NJ 08873 U.S.A.; Made in Japan, 24 units per case; Models CL*EE12NLA - 1.2 m2 surface area, CL*EE15NLA - 1.5 m2 surface area and CL*EE20NLA - 2.0 m2 surface area | Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis. | Terminated | ||
| Z-0791-05 | Terumo Clirans Series E Excebrane Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes (23 microns thick) of vitamin E coated copolymer cellulose housed within a polyurethane casing, filled at the factory with fluid to facilitate priming by the user, and sterilized by autoclaving before shipment; Terumo Corporation, Tokyo 151-0072, Japan; Terumo Medical Corporation, Somerset, NJ 08873 U.S.A.; Made in Japan, 24 units per case; Models CL*E12NLA - 1.2 m2 surface area, CL*E15NLA - 1.5 m2 surface area, CL*E18NLA - 1.8 m2 surface area and CL*E20NLA - 2.0 m2 surface area | Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis. | Terminated | ||
| Z-0790-05 | Asahi APS Series Hollow Fiber Dialyzers; a wet model mutiple use dialyzer consisting of hollow fiber membranes of polysulfone housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Model APS-21R - 2.1 m2 surface area | Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis. | Terminated | ||
| Z-0789-05 | Asahi AM-BIO-HX Extended Range Series Hollow Fiber Dialyzers; a wet model single use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Models AM-BIO-HX-75 - 1.5 m2 surface area and AM-BIO-HX-100 - 2.0 m2 surface area | Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis. | Terminated | ||
| Z-0788-05 | Asahi AM-BIO Series Hollow Fiber Dialyzers; a wet model multiple use dialyzer consisting of hollow fiber membranes of alkyl ether polymer grafted cellulose housed within a plastic casing of styrene butadiene block polymer, filled at the factory with fluid to facilitate priming by the user, and sterilized by gamma radiation before shipment; Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Made in Japan; 12 units per case; Models AM-BIO-65 - 1.3 m2 surface area , AM-BIO-75 - 1.5 m2 surface area and AM-BIO-100 - 2.0 m2 surface area | Exposure to freezing temperatures may damage the hollow fiber dialyzers and result in blood leaks during dialysis. | Terminated | ||
| Z-0739-04 | Asahi APS Series Dialyzers, Model Nos. APS-400S, APS-550S, APS-650S, APS-750S, APS-900S, APS-1050S; the dialyzers are intended for single or initial use and under reprocessing and reuse conditions fo rup to 15 reuse cycles; Manufacturer: Asahi Medical Co., Ltd., 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo 101-8482, Japan; Distributed in teh USA by Nextron Medical, 45 Kulick Road, Fairfield, NJ 07004 USA | Customer reprocessing methods for the reuseable hollow fiber dialyzers may damage the hollow fibers and result in blood leaks during dialysis. | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Asahi Kasei Medical MT Corp. Oita Works edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain