Cleared Traditional

K063755 - PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE

K063755 is an FDA 510(k) clearance for PORTEX HYPODERMIC NEEDLE-PRO FIXED NEED..., manufactured by Smiths Medical Asd, Inc.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K063755 · Smiths Medical Asd, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
70d
Days
Class 2
Risk

K063755 is an FDA 510(k) clearance for the PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE. 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 February 27, 2007 after a review of 70 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K063755

510(k) Number K063755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2006
Decision Date February 27, 2007
Days to Decision 70 days
Submission Type Traditional
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
59d faster than avg
Panel avg: 129d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K063755.
SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC
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K062780 · Medical Device Manufacturer (Thailand) , Ltd. · Jan 2007
BIOTOP HOOKSAFE U-100 INSULIN SYRINGE, MODELS 0.5CC/ML AND 1CC/ML
K062318 · Biotop Technology Co., Ltd. · Jan 2007
OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS
K060971 · Omi Manufacturing Pty., Ltd. · Oct 2006
K063755 · PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE
Download PDF FDA Summary Smiths Medical Asd, I…