Fiberflo Hollow Fiber Capsule Water Filters
FDA 510(k) K983126 · Minntech Corp.
510(k) numberK983126
Submission
- Device name
- Fiberflo Hollow Fiber Capsule Water Filters
- Applicant
- Minntech Corp.
Minneapolis, MN, US - Received
- September 8, 1998
- Decision date
- March 8, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FIP – Subsystem, Water Purification
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5665
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code FIP
| 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 |
|---|---|---|
| K120306 | Rapicide OPA-28MED · Traditional | 09/27/2012SE |
| K092387 | Medivators DSD Edge Endoscope Reprocessing SystemFEB · Traditional | 04/05/2010SE |
| K071298 | HF Junior HemofilterKDI · Traditional | 08/08/2007SE |
| K050952 | HPH Junior High Performance HemoconcentratorKDI · Traditional | 01/31/2006SE |
| K033505 | Renaclean SH Dialyzer Cleaning SystemLIF · Traditional | 04/27/2004SE |
| K014016 | Enguard CHC Dual Reservoir Cardioplegia Heater/CoolerDWC · Traditional | 02/01/2002SE |
| K991137 | Enguard PHX Cardioplegia Heat ExchangerDTR · Traditional | 06/08/2000SE |
| K000028 | Renaflo II HF 2000 HemofilterKDI · Traditional | 04/04/2000SE |
| K991851 | Renaclear Dialyzer Cleaning SystemLIF · Traditional | 08/30/1999SE |
| K983085 | Hemocor HPH 700 HemoconcentratorKDI · Traditional | 11/13/1998SE |
Questions and answers
When was Fiberflo Hollow Fiber Capsule Water Filters cleared by the FDA?
Fiberflo Hollow Fiber Capsule Water Filters (K983126) received a 510(k) decision of Substantially Equivalent on March 8, 1999, 181 days after the submission was received.
What is the product code of K983126?
The FDA product code is FIP – Subsystem, Water Purification, a Class II (moderate risk) device regulated under 21 CFR 876.5665.