510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K014073Substantially Equivalent

Hypodermic Needle-Pro Insulin Syrine & Needle with Needle Protection Device

Abbott Medical, Keene NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K014073 is the FDA 510(k) clearance record for HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE, a class II device, cleared for Portex, Inc. on under FDA product code FMF (Syringe, Piston). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K014073.

Clearance record

Decision date
Received
(65 days to decision)
Product code
FMF Syringe, Piston
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Portex, Inc. 10 Bowman Dr., Keene NH
510(k) summary
Summary
Third party review
No

Clearances, product code FMF

Trailing 12 months
13 clearances under product code FMF in the twelve months to November 2026, December 2025 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code FMF, trailing twelve months
MonthClearances
December 20254
January 20260
February 20261
March 20260
April 20261
May 20261
June 20262
July 20261
August 20263
September 20260
October 20260
November 20260