Cleared Special

K122558 - ULTRASAFE PASSIVE NEEDLE GUARD

K122558 is an FDA 510(k) clearance for ULTRASAFE PASSIVE NEEDLE GUARD, manufactured by Safety Syringes, Inc.. The device is a Class 2 General Hospital device with product code MEG cleared through the Special 510(k) pathway after a 29-day FDA review.

K122558 · Safety Syringes, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
29d
Days
Class 2
Risk

K122558 is an FDA 510(k) clearance for the ULTRASAFE 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 September 20, 2012 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K122558

510(k) Number K122558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2012
Decision Date September 20, 2012
Days to Decision 29 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K122558.
ULTRASAFE PLUS PASSIVE NEEDLE GUARD
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K112936 · Rexam Consummer Plastics Inc.D/B/A Rexam Pharma · Jan 2012
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K111734 · Medicalchain Intl. Corp. · Sep 2011
K122558 · ULTRASAFE PASSIVE NEEDLE GUARD
Download PDF FDA Summary Safety Syringes, Inc.