Cleared Abbreviated

K150562 - Safe'n'Sound Staked Passive Delivery System - Plajex version

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 162
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K150562.
U&U Insulin Syringe with/without Safety Retractable Device
K152808 · U&U Medical Technology Co, Ltd. · Mar 2016
Safety Auto-Disable Syrine with Needle (Auto-Lock)
K143497 · Guangdong Intmed Medical Appliance Co., Ltd. · Nov 2015
Disposable Safety Self-destructive Syringes, 5 ML
K143070 · Jiangsu Yile Medical Article Co., Ltd. · Jul 2015
Disposable sterile needle retractable safety syringe
K141349 · Guangdong Haiou Medical Apparatus Stock Co., Ltd. · Apr 2015
3S Safety Syringe with/without Needle
K142435 · Sincere Medical Device Co., Ltd. · Feb 2015
3S Safety Insulin Syringe
K142436 · Sincere Medical Device Co., Ltd. · Feb 2015
K150562 · Safe'n'Sound Staked Passive Delivery System - Plajex version
Download PDF FDA Summary Nemera