Chrysalis Intelligence · Product Codes · KPO

KPO · Unclassified

17 clearances · 8 unique sponsors

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Device class

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Regulation —

Total clearances

17

2020-01-22 → 2026-01-29

Last 12 months

2

Unique sponsors

8

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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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	9	2	2026-01-29
Nipro Renal Solutions USA, Corp.	2	0	2023-08-04
Deka Research and Development	1	0	2024-07-12
Di-Chem, Inc.	1	0	2022-08-12
Isopure, Corp.	1	0	2020-01-22
Haemopharm Biofluids S.R.L.	1	0	2021-07-23
Renal Care Dialysis Solutions, S.A. DE C.V.	1	0	2023-03-03
Nxstage Medical, Inc.	1	0	2024-01-18

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.

Code	Type	Description	Confidence	Rationale
A4722	HCPCS	Dialysate solution, any concentration of dextrose, fluid volume greater than 1999 cc but less than or equal to 2999 cc, for peritoneal dialysis ✓ CMS-verified description	High	Dialysate concentrate or solution; per 2 liter container, used in hemodialysis
A4720	HCPCS	Dialysate solution, any concentration of dextrose, fluid volume greater than 249 cc, but less than or equal to 999 cc, for peritoneal dialysis ✓ CMS-verified description	Medium	Dialysate concentrate; hemodialysis solution component

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-01-29	K253462	Fresenius Medical Care Renal Therapies Group, LLC	NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)
2025-09-09	K252180	Fresenius Medical Care Renal Therapies Group, LLC	Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)
2025-04-04	K243786	Fresenius Medical Care Renal Therapies Group, LLC	Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)
2024-07-12	K240920	Deka Research and Development	HemoCare Bicarbonate Concentrate Set (BCS)
2024-05-10	K233950	Fresenius Medical Care Renal Therapies Group, LLC	pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)
2024-01-18	K233213	Nxstage Medical, Inc.	NxStage PureFlow Solution
2023-12-01	K233159	Fresenius Medical Care Renal Therapies Group, LLC	pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504
2023-08-04	K223431	Nipro Renal Solutions USA, Corp.	Citric Complete Liquid Citric Acid Concentrate
2023-03-03	K221652	Renal Care Dialysis Solutions, S.A. DE C.V.	NIKKICART
2022-08-12	K202508	Di-Chem, Inc.	Hemo-Lyte C Cartridge
2022-05-12	K212620	Fresenius Medical Care Renal Therapies Group, LLC	Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
2021-07-23	K212052	Haemopharm Biofluids S.R.L.	HMB32 Dialysis Solution
2020-11-25	K193155	Nipro Renal Solutions USA, Corp.	Nipro Dry Complete Dry Acid Concentrate for Hemodialysis
2020-05-08	K192209	Fresenius Medical Care Renal Therapies Group, LLC	Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate
2020-04-24	K192017	Fresenius Medical Care Renal Therapies Group, LLC	Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
2020-02-24	K191474	Fresenius Medical Care Renal Therapies Group, LLC	NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)
2020-01-22	K191093	Isopure, Corp.	Isopure Dry Acid Dissolution System