510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Nipro Renal Solutions USA, Corporation

Lewisberry, PA, US

Nipro Renal Solutions USA, Corporation appears in FDA device records in Lewisberry, PA. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
2
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Nipro Renal Solutions USA, Corporation carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Nipro Renal Soultions USA, Corporationenforcement report, recall

510(k) clearance history

FDA records hold 2 510(k) clearances for Nipro Renal Solutions USA, Corporation between 2020 and 2023. The busiest year on record is 2020, with 1. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for Nipro Renal Solutions USA, Corporation, by decision year
YearClearances
20201
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K223431Citric Complete Liquid Citric Acid ConcentrateKPOSubstantially Equivalent
K193155Nipro Dry Complete Dry Acid Concentrate for HemodialysisKPOSubstantially Equivalent

Registered establishments

FDA registered establishments for Nipro Renal Solutions USA, Corporation, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
15288071000142899Nipro Renal Solutions USA, Corporation509 Fishing Creek Rd, LEWISBERRY, PA 17339 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1730-2025MedicaLyte 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.Class IOpen, Classified
Z-0820-2025Citric Complete - Dry Citric Acid Concentrate Model Number: DCA+225-25The outer case is mislabeled as 3.0 K, 2.0 Ca instead of 2.0 K, 3.0 Ca.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain