Cobe Hemoconcentrator 1.3
FDA 510(k) K823338 · Cobe Laboratories, Inc.
510(k) numberK823338
Submission
- Device name
- Cobe Hemoconcentrator 1.3
- Applicant
- Cobe Laboratories, Inc.
Mchenry, IL, US - Received
- November 8, 1982
- Decision date
- January 7, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5860
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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| K260533 | Elisio-HKDI · Special | Nipro Medical Corporation | 03/19/2026SE |
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| K253518 | FX CorAL 40; FX CorAL 50KDI · Special | Fresenius Medical Care Renal Therapies Group, LLC | 12/18/2025SE |
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| K250508 | AK 98 Dialysis Machine (955607)KDI · Traditional | Vantive US Healthcare, LLC | 08/01/2025SE |
| K243237 | 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T…KDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 06/13/2025SE |
| K243505 | 5008X Hemodialysis SystemKDI · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 05/30/2025SE |
More from Fresenius Medical Care Renal Therapies Group, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K923272 | Cobe Cms-Hf Hollow Fiber Membrane OxygenatorDTZ · Traditional | 05/11/1993SE |
| K900105 | Cobe Spectra Blood Component Separator TherapeuticLKN · Traditional | 03/22/1991SE |
| K905793 | Cobe Centry 2 Bicart Option KitFKP · Traditional | 02/12/1991SE |
| K905388 | Cobe Centrysystem 3 Bicart Option KitFKP · Traditional | 02/11/1991SE |
| K904336 | New Cobe Saturation/Hematocrit MonitorGKF · Traditional | 12/27/1990SE |
| K902631 | Cobe ICU Conversion KitDTN · Traditional | 12/17/1990SE |
| K902437 | Cobe Cardiotomy Reservoir with or Without FilterDTP · Traditional | 12/17/1990SE |
| K904566 | New Cobe Centrysystem(Tm) 100 HG DialyzerFJI · Traditional | 12/12/1990SE |
| K902758 | Cobe Saturation/Hematocrit Monitor W/ Fiber OpticDQA · Traditional | 08/23/1990SE |
| K902759 | Cobe Closed Wound Drainage KitCAC · Traditional | 07/18/1990SE |
Questions and answers
When was Cobe Hemoconcentrator 1.3 cleared by the FDA?
Cobe Hemoconcentrator 1.3 (K823338) received a 510(k) decision of Substantially Equivalent on January 7, 1983, 60 days after the submission was received.
What is the product code of K823338?
The FDA product code is KDI – Dialyzer, High Permeability With Or Without Sealed Dialysate System, a Class II (moderate risk) device regulated under 21 CFR 876.5860.