Cleared Abbreviated

K061194 - PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558

K061194 is an FDA 510(k) clearance for PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, manufactured by Smiths Medical Asd, Inc.. The device is a Class 2 General Hospital device with product code MEG cleared through the Abbreviated 510(k) pathway after a 118-day FDA review.

K061194 · Smiths Medical Asd, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
118d
Days
Class 2
Risk

K061194 is an FDA 510(k) clearance for the PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 43.... Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Smiths Medical Asd, Inc. (Keene, US). The FDA issued a Cleared decision on August 24, 2006 after a review of 118 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 - K061194

510(k) Number K061194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2006
Decision Date August 24, 2006
Days to Decision 118 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
11d faster than avg
Panel avg: 129d · This submission: 118d
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 K061194.
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K053519 · Wuxi Yushou Medical Applicances Co., Ltd. · Aug 2006
CAREO SAFETY SYRINGE FOR U-100 INSULIN
K061055 · Life-Shield Products, Inc. · Jul 2006
SAFE TIP SYRINGE
K060668 · Devon Safety Products, Inc. · Jun 2006
K061194 · PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558
Download PDF FDA Summary Smiths Medical Asd, I…