Cleared Abbreviated

K112936 - SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM

K112936 is an FDA 510(k) clearance for SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY ..., manufactured by Rexam Consummer Plastics Inc.D/B/A Rexam Pharma. The device is a Class 2 General Hospital device with product code MEG cleared through the Abbreviated 510(k) pathway after a 109-day FDA review.

K112936 · Rexam Consummer Plastics Inc.D/B/A Rexam Pharma · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
109d
Days
Class 2
Risk

K112936 is an FDA 510(k) clearance for the SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Rexam Consummer Plastics Inc.D/B/A Rexam Pharma (Buffalo Grove, US). The FDA issued a Cleared decision on January 20, 2012 after a review of 109 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 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 - K112936

510(k) Number K112936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2011
Decision Date January 20, 2012
Days to Decision 109 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
20d faster than avg
Panel avg: 129d · This submission: 109d
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 K112936.
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AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE)
K113587 · Shantou Wealy Medical Instrument Co.,Ltd · Feb 2012
MYSAFETY SYRINGE
K111734 · Medicalchain Intl. Corp. · Sep 2011
MEDLINE RETRACTABLE SAFETY SYRINGE
K101560 · Medline Industries, Inc. · Mar 2011
SAFE'N'SOUND PASSIVE DELIVERY SYSTEM
K101233 · Rexam Pharma · Feb 2011
K112936 · SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM
Download PDF FDA Summary Rexam Consummer Plast…