510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K222852Substantially Equivalent

Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle

Nipro Medical Corporation, Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222852 is the FDA 510(k) clearance record for Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle, a class II device, cleared for Nipro Medical Corporation on under FDA product code FMI (Needle, Hypodermic, Single Lumen). FDA records list 62 510(k) clearances for Nipro Medical Corporation, from to . As of , FDA records show no recalls naming K222852.

Clearance record

Decision date
Received
(246 days to decision)
Product code
FMI Needle, Hypodermic, Single Lumen
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Nipro Medical Corporation 3150 NW 107th Ave., Miami FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FMI

Trailing 12 months
13 clearances under product code FMI in the twelve months to October 2026, March 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code FMI, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20263
April 20261
May 20260
June 20261
July 20262
August 20263
September 20261
October 20260