Exp* 500 Parallel Plate Dialyzer
FDA 510(k) K840057 · Extracorporeal Medical Specialities, Inc.
510(k) numberK840057
Submission
- Device name
- Exp* 500 Parallel Plate Dialyzer
- Applicant
- Extracorporeal Medical Specialities, Inc.
Mchenry, IL, US - Received
- January 9, 1984
- Decision date
- February 4, 1984
- 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
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| 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 |
|---|---|---|
| K843955 | Extracorporeal Maxima Hollow Fiber OxygenatorDTZ · Traditional | 11/29/1984SE |
| K840532 | Hemoperfusion System TP-400FLD · Traditional | 05/30/1984SE |
| K840262 | Hancock Pericardial PatchDXZ · Traditional | 05/30/1984SE |
| K840146 | Exp* 700 Parallel Plate DialyzerKOC · Traditional | 02/04/1984SE |
| K832547 | Ultrafiltration ControllerKDI · Traditional | 01/03/1984SE |
| K831423 | Therapeutic Exchange SystemLQQ · Traditional | 01/03/1984SE |
| K833477 | Intersept 40 Micron FilterDTM · Traditional | 12/27/1983SE |
| K833476 | Intersept 40 Micron Filter W/TubingDTM · Traditional | 12/27/1983SE |
| K831424 | Therapeutic Exchange Blood TUBING-TP-101FJK · Traditional | 10/14/1983SE |
| K832053 | Single Patient Sys. II Model DM-450KOC · Traditional | 09/29/1983SE |
Questions and answers
When was Exp* 500 Parallel Plate Dialyzer cleared by the FDA?
Exp* 500 Parallel Plate Dialyzer (K840057) received a 510(k) decision of Substantially Equivalent on February 4, 1984, 26 days after the submission was received.
What is the product code of K840057?
The FDA product code is KOC – Accessories, Blood Circuit, Hemodialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.