Cleared Traditional

K073206 - NEEDLE-TRAP/NEEDLE SAFETY LABEL

K073206 is an FDA 510(k) clearance for NEEDLE-TRAP/NEEDLE SAFETY LABEL, manufactured by Schreiner Medipharm. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K073206 · Schreiner Medipharm · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
64d
Days
Class 2
Risk

K073206 is an FDA 510(k) clearance for the NEEDLE-TRAP/NEEDLE SAFETY LABEL. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Schreiner Medipharm (Fort Myers, US). The FDA issued a Cleared decision on January 16, 2008 after a review of 64 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.

View all Schreiner Medipharm devices

FDA 510(k) Submission Details - K073206

510(k) Number K073206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2007
Decision Date January 16, 2008
Days to Decision 64 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 129d · This submission: 64d
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 55
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K073206.
Self-destruction Safety Syringes for Single Use
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MEDLINE RETRACTABLE SAFETY SYRINGE
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K103011 · Ulti-Med Intl., Inc. · Feb 2011
HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY
K072482 · Smiths Medical Asd, Inc. · Nov 2007
PORTEX HYPODERMIC NEEDLE-PRO FIXED NEEDLE SYRINGE
K063755 · Smiths Medical Asd, Inc. · Feb 2007
PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558
K061194 · Smiths Medical Asd, Inc. · Aug 2006