Data / Medical devices / United States / Nipro Renal Solutions USA, Corporation
Nipro Renal Solutions USA, Corporation: FDA-registered device maker in Lewisberry, PA, United States, 5 510(k) clearances
Nipro Renal Solutions USA, Corporation is registered with the FDA (registration 1528807) in Lewisberry, PA, United States. It lists 1 device type. The FDA files 5 510(k) clearances under its listings, the newest dated August 4, 2023. 3 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1528807
- FEI number
- 1000142899
- Address
- 509 Fishing Creek Rd, Lewisberry, PA, United States, 17339
- Owner or operator
- Nipro Renal Solutions USA, Corp (10035998)
- Roles
- Manufacturer
- First device listed
- May 25, 2011
- Registered through
- 2026
- Brand names listed
- Citric Complete, Citric Complete Liquid Citric Acid Concentrate, MedicaLyte, MedicaPure
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 4, 2023 | K223431 | Citric Complete Liquid Citric Acid Concentrate | KPO | Substantially Equivalent | Nipro Renal Solutions USA, Corp. | accessdata.fda.gov |
| March 6, 2018 | K171750 | Citric Complete Dry Citric Acid (45X) | KPO | Substantially Equivalent | Dimesol USA, LLC | accessdata.fda.gov |
| April 3, 2014 | K131202 | MEDICALYTE(R) BICARBONATE POWDER (36.83X), MEDICALYTE(R) BICARBONATE POWDER (45X), MEDICALYTE(R) BICARBONATE POWDER (35X | KPO | Substantially Equivalent | Dialysis Medical Solutions, LLC | accessdata.fda.gov |
| January 18, 2002 | K012547 | HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION | KPO | Substantially Equivalent | Di-Chem, Inc. | accessdata.fda.gov |
| July 27, 1990 | K901471 | GC-1000 THROUGH GC-3005 ACID CONCENTRATE | KPO | Substantially Equivalent | Granite Chemical Co., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 5, 2026 | 99573 | Class II | Ongoing | MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201 | Hemodialysis concentrates contain high endotoxin levels | accessdata.fda.gov |
| April 11, 2025 | 96646 | Class I | Ongoing | MedicaLyte Liquid Bicarbonate Concentrate. Model Numbers: BC+201 (45X), BC+100 36.83X. Plastic bottle packaged in corrugated shipper cases (4 bottles per shipper case). | Potential for the presence of visible foreign matter. | accessdata.fda.gov |
| November 22, 2024 | 95878 | Class II | Ongoing | Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25 | The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca. | accessdata.fda.gov |
Compare with other makers
Updated September 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.