Cleared Traditional

INFUSET W/HUBER NEEDLE (K844313) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844313 · Med Fusion Systems, Inc. · General Hospital
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Jan 1985
Decision
77d
Days
Class 2
Risk

K844313 is an FDA 510(k) clearance for the INFUSET W/HUBER NEEDLE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Med Fusion Systems, Inc. (Marietta, US). The FDA issued a Cleared decision on January 22, 1985 after a review of 77 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 Med Fusion Systems, Inc. devices

Submission Details

510(k) Number K844313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1984
Decision Date January 22, 1985
Days to Decision 77 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
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 181
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K844313.
MONOJECT STERILE M216 BLOOD COLLECTION NEEDLES
K854548 · Sherwood Medical Co. · Feb 1986
MONOJECT STERILE M400 PLASTIC&STERILE M401 ALUMINU
K854549 · Sherwood Medical Co. · Feb 1986
VASCULAR IMPLANT ACCESS NEEDLE SET
K851103 · Baxter Healthcare Corp · Jul 1985
MONOJECT MENGHINI SOFT TISSUE BIOPSY
K843264 · Sherwood Medical Co. · Dec 1984
INTRADISCAL THERAPY TRAY
K834553 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1984
INTRADISCAL THERAPY NEEDLE
K831610 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1983