Cleared Traditional

DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES (K950012) - FDA 510(k) Clearance

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

K950012 · International Regulatory Consultants · General Hospital
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Aug 1995
Decision
227d
Days
Class 2
Risk

K950012 is an FDA 510(k) clearance for the DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by International Regulatory Consultants (Flushing, US). The FDA issued a Cleared decision on August 18, 1995 after a review of 227 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all International Regulatory Consultants devices

Submission Details

510(k) Number K950012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1995
Decision Date August 18, 1995
Days to Decision 227 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 129d · This submission: 227d
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 191
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K950012.
B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE
K955235 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1996
SAFETYGLIDE NEEDLE
K951254 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1995
BECTON DICKINSON BLUNT STEEL CANNULA
K944931 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1995
MONOJECT VERTICAL ENTRY CHEMOTHERAPY SHARPS CONTAINER
K951515 · Sherwood Medical Co. · May 1995
B-D ULTRA-FINE II PEN NEEDLE
K950466 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1995
MONOJECT(R) VERTICAL ENTRY SHARPS CONTAINER (1 QT)
K945809 · Sherwood Medical Co. · Mar 1995