Cleared Abbreviated

K141664 - SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION

K141664 is an FDA 510(k) clearance for SAFE'N'SOUND STAKED PASSIVE DELIVERY SY..., manufactured by Rexam Healthcare. The device is a Class 2 General Hospital device with product code MEG cleared through the Abbreviated 510(k) pathway after a 101-day FDA review.

K141664 · Rexam Healthcare · General Hospital
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Oct 2014
Decision
101d
Days
Class 2
Risk

K141664 is an FDA 510(k) clearance for the SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Rexam Healthcare (La Verpilliere, FR). The FDA issued a Cleared decision on October 2, 2014 after a review of 101 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 Healthcare devices

FDA 510(k) Submission Details - K141664

510(k) Number K141664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2014
Decision Date October 02, 2014
Days to Decision 101 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
28d faster than avg
Panel avg: 129d · This submission: 101d
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 140
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K141664.
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SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE
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TIANKANG DISPOSABLE SYRINGES WITH RE-USE PREVENTION FEATURE WITH OR WITHOUT NEEDLE
K131531 · Anhui Tiankang Medical Products Co., Ltd. · May 2014