Centry 2 System #016, 103, 016, 104
FDA 510(k) K791086 · Cobe Laboratories, Inc.
510(k) numberK791086
Submission
- Device name
- Centry 2 System #016, 103, 016, 104
- Applicant
- Cobe Laboratories, Inc.
Mchenry, IL, US - Received
- June 12, 1979
- Decision date
- July 3, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FIP – Subsystem, Water Purification
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5665
- Specialty
- Gastroenterology, Urology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250471 | AquaC UNO HFIP · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 11/14/2025SE |
| K251851 | DIASAFEplusUS (F00013010)FIP · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 10/09/2025SE |
| K252181 | AquaAFIP · Traditional | Fresenius Medical Care North America | 09/09/2025SE |
| K250514 | UPT Series Medical RO Water Treatment SystemFIP · Special | Specialty Water Technologies, Inc. | 03/17/2025SE |
| K232953 | AquaBplus; AquaB LITEFIP · Traditional | Fresenius Medical Care Renal Therapies Group, LLC | 06/13/2024SE |
| K223479 | AQUAbase nXFIP · Traditional | B.Braun Medical, Inc. | 08/16/2023SE |
| K231410 | RenaPure Endotoxin Retentive FilterFIP · Traditional | Evoqua Water Technologies, LLC | 07/19/2023SE |
| K223656 | AmeriWater MediQA Reverse Osmosis System (MSP3HF)FIP · Special | AmeriWater, LLC | 02/13/2023SE |
| K213507 | AquaAFIP · Traditional | Fresenius Medical Care Rental Therapies Group, LLC | 07/27/2022SE |
| K211035 | U9000 Plus UltrafilterFIP · Traditional | Baxter Healthcare Corporation | 10/19/2021SE |
More from Baxter Healthcare Corporation
| 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 Centry 2 System #016, 103, 016, 104 cleared by the FDA?
Centry 2 System #016, 103, 016, 104 (K791086) received a 510(k) decision of Substantially Equivalent on July 3, 1979, 21 days after the submission was received.
What is the product code of K791086?
The FDA product code is FIP – Subsystem, Water Purification, a Class II (moderate risk) device regulated under 21 CFR 876.5665.