510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K970076Substantially Equivalent

Nipro Disposable Solution Infusion Set

Nipro Medical Corporation, Lexington KY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970076 is the FDA 510(k) clearance record for NIPRO DISPOSABLE SOLUTION INFUSION SET, a class II device, cleared for Nipro Medical Corp. on under FDA product code FPA (Set, Administration, Intravascular). FDA records list 62 510(k) clearances for Nipro Medical Corp., from to . As of , FDA records show no recalls naming K970076.

Clearance record

Decision date
Received
(77 days to decision)
Product code
FPA Set, Administration, Intravascular
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Nipro Medical Corp. 1384 Copperfield Ct., Lexington KY
510(k) summary
Summary
Third party review
No

Clearances, product code FPA

Trailing 12 months
6 clearances under product code FPA in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FPA, trailing twelve months
MonthClearances
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20261
October 20261
November 20260