Cleared Traditional

K944425 - ULTRASAFE ASPIRATING SYRINGE

K944425 is the FDA 510(k) clearance for ULTRASAFE ASPIRATING SYRINGE by Safety Syringes, Inc.. It is a Class 2 General Hospital device (product code MEG) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K944425 · Safety Syringes, Inc. · General Hospital
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Jan 1995
Decision
136d
Days
Class 2
Risk

K944425 is an FDA 510(k) clearance for the ULTRASAFE ASPIRATING SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Safety Syringes, Inc. (Arcadia, US). The FDA issued a Cleared decision on January 26, 1995 after a review of 136 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 Safety Syringes, Inc. devices

Submission Details

510(k) Number K944425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1994
Decision Date January 26, 1995
Days to Decision 136 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
7d slower than avg
Panel avg: 129d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEG Syringe, Antistick
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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.