Cleared Abbreviated

K150562 - Safe'n'Sound Staked Passive Delivery Sy...

K150562 is an FDA 510(k) clearance for Safe'n'Sound Staked Passive Delivery Sy..., manufactured by Nemera. The device is a Class 2 General Hospital device with product code MEG cleared through the Abbreviated 510(k) pathway after a 88-day FDA review.

K150562 · Nemera · General Hospital
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Jun 2015
Decision
88d
Days
Class 2
Risk

K150562 is an FDA 510(k) clearance for the Safe'n'Sound Staked Passive Delivery System - Plajex version. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Nemera (Buffalo Grove, US). The FDA issued a Cleared decision on June 2, 2015 after a review of 88 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Nemera devices

FDA 510(k) Submission Details - K150562

510(k) Number K150562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2015
Decision Date June 02, 2015
Days to Decision 88 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 129d · This submission: 88d
Pathway characteristics
Standards-based clearance path.

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 43
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K150562.
Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use
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MEDLINE RETRACTABLE SAFETY SYRINGE
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ULTICARE SAFETY INSULIN SYRINGE
K103011 · Ulti-Med Intl., Inc. · Feb 2011
HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY
K072482 · Smiths Medical Asd, Inc. · Nov 2007