Chrysalis Intelligence · Product Codes · FIP

FIP · Unclassified

11 clearances · 9 unique sponsors

Device class
Regulation —
Total clearances
11
2020-04-16 → 2025-11-14
Last 12 months
3
Unique sponsors
9
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Fresenius Medical Care Renal Therapies Group, LLC 3 2 2025-11-14
Baxter Healthcare Corporation 1 0 2021-10-19
Mar Cor Purification, Inc. 1 0 2020-04-16
Evoqua Water Technologies, LLC 1 0 2023-07-19
Specialty Water Technologies, Inc. 1 0 2025-03-17
Fresenius Medical Care North America 1 1 2025-09-09
Fresenius Medical Care Rental Therapies Group, LLC 1 0 2022-07-27
B.Braun Medical, Inc. 1 0 2023-08-16
AmeriWater, LLC 1 0 2023-02-13
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
E1610 HCPCS Reverse osmosis water purification system, for hemodialysis ✓ CMS-verified description Medium Dialysis water purification system/supplies component
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-11-14 K250471 Fresenius Medical Care Renal Therapies Group, LLC AquaC UNO H
2025-10-09 K251851 Fresenius Medical Care Renal Therapies Group, LLC DIASAFEplusUS (F00013010)
2025-09-09 K252181 Fresenius Medical Care North America AquaA
2025-03-17 K250514 Specialty Water Technologies, Inc. UPT Series Medical RO Water Treatment System
2024-06-13 K232953 Fresenius Medical Care Renal Therapies Group, LLC AquaBplus; AquaB LITE
2023-08-16 K223479 B.Braun Medical, Inc. AQUAbase nX
2023-07-19 K231410 Evoqua Water Technologies, LLC RenaPure Endotoxin Retentive Filter
2023-02-13 K223656 AmeriWater, LLC AmeriWater MediQA Reverse Osmosis System (MSP3HF)
2022-07-27 K213507 Fresenius Medical Care Rental Therapies Group, LLC AquaA
2021-10-19 K211035 Baxter Healthcare Corporation U9000 Plus Ultrafilter
2020-04-16 K200670 Mar Cor Purification, Inc. EON Portable RO Water Purification System