Cleared Abbreviated

SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM (K112936) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K112936 · Rexam Consummer Plastics Inc.D/B/A Rexam Pharma · General Hospital
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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.

View all Rexam Consummer Plastics Inc.D/B/A Rexam Pharma devices

Submission Details

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
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 129d · This submission: 109d
Pathway characteristics
Standards-based clearance path.

Device Classification

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.

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