Cleared Traditional

K874414 - HYPODERMIC NEEDLES, SINGLE LUMEN

K874414 is an FDA 510(k) clearance for HYPODERMIC NEEDLES, manufactured by Harbor Medical Devices, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K874414 · Harbor Medical Devices, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1988
Decision
78d
Days
Class 2
Risk

K874414 is an FDA 510(k) clearance for the HYPODERMIC NEEDLES, SINGLE LUMEN. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Harbor Medical Devices, Inc. (Boston, US). The FDA issued a Cleared decision on January 14, 1988 after a review of 78 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Harbor Medical Devices, Inc. devices

FDA 510(k) Submission Details - K874414

510(k) Number K874414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1987
Decision Date January 14, 1988
Days to Decision 78 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 129d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 502
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K874414.
NON-CORING NEEDLES
K883009 · Quinton, Inc. · Oct 1988
VIGGO VASCUPORT NEEDLE
K881758 · Ohmeda Medical · Jun 1988
BLOOD COLLECTING NEEDLE AND HOLDERS
K880892 · Abco Dealers, Inc. · Apr 1988
CHEMO-PORT NON-CORING NEEDLES
K873165 · Hdc Corp. · Dec 1987
HR(TM) NEEDLE AND SYRINGE
K874372 · Icu Medical, Inc. · Nov 1987
BLOOD NEEDLE HOLDER
K873569 · Sage Products, Inc. · Nov 1987