Nipro Medical Corporation: FDA filings under this applicant name

FDA lists 62 510(k) clearances under the applicant name “Nipro Medical Corporation” (first 1997, latest 2026), across 20 product codes in 4 review panels. Median 510(k) review time under this name: 116 days. Since 2017 the median was 234 days, against 169 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Nipro Medical Corporation took a median 234 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 169 days.

Top product codes

Plus 10 more product codes.

Review panels

• General Hospital (33)
• Gastroenterology and Urology (24)
• Cardiovascular (4)
• Clinical Chemistry (1)

Most recent Nipro Medical Corporation 510(k) clearances

52 earlier clearances. See the full list in Caduvo.

Recalls

12 product recalls in 8 recall events; 1 initiated in the last five years. Most recent: 2025-10-27.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Device clinical trials

An industry sponsor named Nipro Medical Corporation is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT07058909: Premarket Clinical Safety Assessment of the ELISIO™-HX (Completed, started 2025-09-08)

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Nipro Medical Corporation (a text match, not an official crosswalk):

• A4220 — Refill kit for implantable infusion pump (via MEB)
• E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MEB)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Nipro Diabetes Systems, Inc. (5 510(k)s)
• Nipro Diagnostics, Inc. (4 510(k)s)
• Nipro Renal Solutions USA, Corp. (2 510(k)s)
• Nipro Company, Ltd. (1 510(k)s)
• Nipro Technical Solutions, Incoporated (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Nipro Medical Corporation?

FDA lists 62 510(k) clearances under the applicant name “Nipro Medical Corporation” (first 1997, latest 2026), across 20 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Nipro Medical Corporation?

The median time from FDA receipt to decision across 510(k)s cleared under the name Nipro Medical Corporation is 116 days. Since 2017: 234 days, versus 169 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Nipro Medical Corporation?

The most frequent FDA product codes under this applicant name are FMF (Syringe, Piston, 9); FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 8); KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 8).

Next steps

• See all 62 Nipro Medical Corporation clearances with predicates and recalls
• Run predicate analysis for product code FMF, Nipro Medical Corporation's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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