AquaBplus; AquaB LITE
FDA 510(k) clearance K232953 · decided 2024-06-13
Clearance details
- K-number
- K232953
- Device name
- AquaBplus; AquaB LITE
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-09-21
- Decision date
- 2024-06-13
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- FIP
- Device class
- 2
- Regulation number
- 876.5665
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Waltham, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AquaC UNO H (K250471) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-11-14 |
| DIASAFEplusUS (F00013010) (K251851) | Fresenius Medical Care Renal Therapies Group, LLC | 2025-10-09 |
| AquaA (K252181) | Fresenius Medical Care North America | 2025-09-09 |
| UPT Series Medical RO Water Treatment System (K250514) | Specialty Water Technologies, Inc. | 2025-03-17 |
| AQUAbase nX (K223479) | B.Braun Medical, Inc. | 2023-08-16 |
| RenaPure Endotoxin Retentive Filter (K231410) | Evoqua Water Technologies, LLC | 2023-07-19 |
| AmeriWater MediQA Reverse Osmosis System (MSP3HF) (K223656) | AmeriWater, LLC | 2023-02-13 |
| AquaA (K213507) | Fresenius Medical Care Rental Therapies Group, LLC | 2022-07-27 |
| U9000 Plus Ultrafilter (K211035) | Baxter Healthcare Corporation | 2021-10-19 |
| EON Portable RO Water Purification System (K200670) | Mar Cor Purification, Inc. | 2020-04-16 |
| Millenium HX (K192398) | Mar Cor Purification, Inc. | 2019-10-03 |
| DIASAFEplusUS (K182367) | Fresenius Medical Care Renal Therapies Group, LLC | 2019-01-10 |
Recalls involving this device
No recalls on record reference this clearance.