510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001879Substantially Equivalent

Infusion IV Set

Nirvi Intl. USA, Pittsburg PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001879 is the FDA 510(k) clearance record for INFUSION IV SET, a class II device, cleared for Nirvi Intl. USA on under FDA product code LRS (I.V. Start Kit). FDA's definition for product code LRS reads: "This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at...". FDA records list one 510(k) clearance for Nirvi Intl. USA. As of , FDA records show no recalls naming K001879.

Clearance record

Decision date
Received
(518 days to decision)
Product code
LRS I.V. Start Kit
Regulation
21 CFR 880.5200
Device class
Class II
Review panel
General Hospital
Applicant
Nirvi Intl. USA 467 Diablo Dr., Pittsburg PA
510(k) summary
Statement
Third party review
No

Clearances, product code LRS

Trailing 12 months

FDA records hold no clearances under product code LRS in the trailing twelve months.

FDA records show no clearances under product code LRS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LRS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260