510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230951Substantially Equivalent

Terumo Injection Filter Needle (NF-3013RBKE05M)

Terumo Europe N.V., Leuven, BE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230951 is the FDA 510(k) clearance record for Terumo Injection Filter Needle (NF-3013RBKE05M), a class II device, cleared for Terumo Europe N.V. on under FDA product code QYM (Ophthalmic Needle). FDA's definition for product code QYM reads: "An Ophthalmic Needle is a needle intended for intraocular injections. The device should be used by health care professionals to perform injections into the eye". FDA records list 28 510(k) clearances for Terumo Europe N.V., from to . As of , FDA records show no recalls naming K230951.

Clearance record

Decision date
Received
(197 days to decision)
Product code
QYM Ophthalmic Needle
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Terumo Europe N.V. Interleuvenlaan 40, Leuven, BE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QYM

Trailing 12 months

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

FDA records show no clearances under product code QYM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QYM, 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