Cleared Traditional

K950686 - I.V. START KIT

K950686 is an FDA 510(k) clearance for I.V. START KIT, manufactured by James J. Schramm. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 618-day FDA review.

K950686 · James J. Schramm · General Hospital
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Oct 1996
Decision
618d
Days
Class 2
Risk

K950686 is an FDA 510(k) clearance for the I.V. START KIT. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by James J. Schramm (Lake Villa, US). The FDA issued a Cleared decision on October 24, 1996 after a review of 618 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

FDA 510(k) Submission Details - K950686

510(k) Number K950686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1995
Decision Date October 24, 1996
Days to Decision 618 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
489d slower than avg
Panel avg: 129d · This submission: 618d
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 635
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K950686.
MANAN PEDIATRIC BONE MARROW ACCESS NEEDLE
K962001 · Manan Medical Products, Inc. · Jan 1997
SERAGARD VASCULAR ACCESS DEVICE
K963595 · Cutting Edge Technologies, Inc. · Jan 1997
MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA
K960982 · Sherwood Medical Co. · Dec 1996
SAFETY CRADLE
K962149 · Specialized Health Products, Inc. · Oct 1996
BIO-PLEXUS NEEDLE DISPOSAL CONTAINER
K960933 · Bio-Plexus, Inc. · Aug 1996
PISTON SYRINGE
K961877 · Univec, Inc. · Aug 1996
K950686 · I.V. START KIT
Download PDF James J. Schramm