JMS Dialyzer Priming Set
FDA 510(k) K983707 · Jms Co., Ltd.
510(k) numberK983707
Submission
- Device name
- JMS Dialyzer Priming Set
- Applicant
- Jms Co., Ltd.
Hiroshima, JP - Received
- October 21, 1998
- Decision date
- January 8, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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
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| 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 |
|---|---|---|
| K041159 | JMS Absorbable Anchor and ApplicatorGDW · Traditional | 07/27/2004SE |
| K002352 | JMS A.V. Fistula Needle Set Accordion TypeFIE · Traditional | 09/06/2001SE |
| K002394 | JMS Apheresis Needle Set Accordion TypeFMI · Traditional | 09/05/2001SE |
| K010410 | JMS Apheresis Needle Wing Eater, Model 14G-18GFOZ · Traditional | 06/20/2001SE |
| K010406 | JMS A.V. Fistula Needle Set Wing Eater, Model 14G-18GFOZ · Traditional | 06/20/2001SE |
| K000845 | Modification to JMS A.V. Fistula Needle SetFIE · Special | 04/10/2000SE |
| K000843 | Modification to JMS Apheresis NeedleFIE · Special | 04/10/2000SE |
| K991904 | Modification of JMS Needles and JMS SyringesFMI · Traditional | 08/31/1999SE |
| K990510 | JMS Apheresis NeedleFIE · Traditional | 08/30/1999SE |
| K990470 | JMS A. V. Fistula Needle SetFIE · Traditional | 08/30/1999SE |
Questions and answers
When was JMS Dialyzer Priming Set cleared by the FDA?
JMS Dialyzer Priming Set (K983707) received a 510(k) decision of Substantially Equivalent on January 8, 1999, 79 days after the submission was received.
What is the product code of K983707?
The FDA product code is KOC – Accessories, Blood Circuit, Hemodialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.