Cleared Traditional

K950012 - DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES (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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
99d slower than avg
Panel avg: 128d · 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 688
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K950012.
Verisafe Safety Sterile Needles (SSN)
K254273 · Promisemed Hangzhou Meditech Co., Ltd. · Apr 2026
Easydrip Classic Pen Needle
K252908 · Sandstone Medical (Suzhou), Inc. · Mar 2026
PRESSONE™
K253047 · Nipro Medical Corporation · Mar 2026
Safety Pen Needle
K253622 · Ningbo Medsun Medical Co., Ltd. · Mar 2026
Pen Needle
K252886 · Hh Global Technology, Inc. · Jan 2026
Pen Injector Needle 32.5
K250700 · Terumo Corporation · Nov 2025