Cleared Traditional

K123743 - ULTRASAFE PLUS PASSIVE NEEDLE GUARD

K123743 is an FDA 510(k) clearance for ULTRASAFE PLUS PASSIVE NEEDLE GUARD, manufactured by Safety Syringes, Inc.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K123743 · Safety Syringes, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
110d
Days
Class 2
Risk

K123743 is an FDA 510(k) clearance for the ULTRASAFE PLUS PASSIVE NEEDLE GUARD. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Safety Syringes, Inc. (Carlsbad, US). The FDA issued a Cleared decision on March 26, 2013 after a review of 110 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.

FDA 510(k) Submission Details - K123743

510(k) Number K123743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2012
Decision Date March 26, 2013
Days to Decision 110 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 129d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEG Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MEG Syringe, Antistick

All 162
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K123743.
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GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE
K120641 · Global Medi Products · Oct 2012
ULTRASAFE PASSIVE NEEDLE GUARD
K122558 · Safety Syringes, Inc. · Sep 2012
K123743 · ULTRASAFE PLUS PASSIVE NEEDLE GUARD
Download PDF FDA Summary Safety Syringes, Inc.