Asahi Hollow Fiber Kidneys, Am-Series
FDA 510(k) K830231 · Advocacy International, Ltd.
510(k) numberK830231
Submission
- Device name
- Asahi Hollow Fiber Kidneys, Am-Series
- Applicant
- Advocacy International, Ltd.
Mchenry, IL, US - Received
- January 18, 1983
- Decision date
- March 17, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KOC – Accessories, Blood Circuit, Hemodialysis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
Other 510(k)s with product code KOC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K242479 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR…KOC · Traditional | Nikkiso Co., Ltd. | 05/15/2025SE |
| K242176 | BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR…KOC · Traditional | Nikkiso Co., Ltd. | 05/15/2025SE |
| K231589 | Blood Tubing Lines for Hemodialysis AV06C-EKOC · Traditional | Nikkiso Co., Ltd. | 07/28/2023SE |
| K230514 | Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for…KOC · Traditional | Nikkiso Co., Ltd. | 06/16/2023SE |
| K201207 | CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated…KOC · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 09/18/2020SE |
| K172238 | CAREline Airless Hemodialysis Blood Tubing SetsKOC · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 12/14/2017SE |
| K160749 | CRIT-LINE III Blood Chamber IIKOC · Special | Fresenius Medical Care Renal Therapies Group, LLC | 04/15/2016SE |
| K152953 | Crit-Line Clip (Clic) Blood ChamberKOC · Special | Fresenius Medical Care North America | 11/05/2015SE |
| K141997 | Crit-Line IV SystemKOC · Traditional | Fresenius Medical Care | 04/01/2015SE |
| K141281 | Crit-Line Clip (Clic) Blood ChamberKOC · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 08/14/2014SE |
More from Fresenius Medical Care Renal Therapies Group, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K874027 | Lipase UV [Toyo]CHI · Traditional | 05/27/1988SE |
| K873792 | Sepacell R-500 and Sepacell R-500ACAK · Traditional | 01/19/1988SE |
| K855251 | Modification Asahi New Pan-Series HemofiltersKDI · Traditional | 02/04/1986SE |
| K855212 | Asahi Am Series DialyzersFJI · Traditional | 01/21/1986SE |
| K854259 | Sepacell R-500 & Sepacell R-500ACAK · Traditional | 01/08/1986SE |
| K842103 | Toyo Jozo Uric Acid TestKNK · Traditional | 08/12/1984SE |
| K842104 | Toyo Jozo G-Gtp TestJPZ · Traditional | 08/10/1984SE |
| K830183 | Asahi Hollow Fiber Kidneys NR SeriesKOC · Traditional | 03/17/1983SE |
| K823733 | Eiken Kizai Artificial Kidney Blood CirKOC · Traditional | 01/14/1983SE |
| K813037 | Flowguard Catheters & CannalaeDWF · Traditional | 12/14/1981SE |
Questions and answers
When was Asahi Hollow Fiber Kidneys, Am-Series cleared by the FDA?
Asahi Hollow Fiber Kidneys, Am-Series (K830231) received a 510(k) decision of Substantially Equivalent on March 17, 1983, 58 days after the submission was received.
What is the product code of K830231?
The FDA product code is KOC – Accessories, Blood Circuit, Hemodialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.