510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050464Substantially Equivalent

Ultracare Disposable Pen Needles, Models 31 Gauge X3/16, 29 Gauge X 1/2

Ultimed, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050464 is the FDA 510(k) clearance record for ULTRACARE DISPOSABLE PEN NEEDLES, MODELS 31 GAUGE X3/16, 29 GAUGE X 1/2, a class II device, cleared for Ultimed, Inc. on under FDA product code FMI (Needle, Hypodermic, Single Lumen). FDA records list 8 510(k) clearances for Ultimed, Inc., from to . As of , FDA records show no recalls naming K050464.

Clearance record

Decision date
Received
(77 days to decision)
Product code
FMI Needle, Hypodermic, Single Lumen
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Ultimed, Inc. 5353 Wayzata Blvd., Suite 505, Minneapolis MN
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