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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 162
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K073206.
1ML UNITRACT INSULIN SYRINGE 27G*1/2 , 1ML UNITRACT SYRINGE 29G*1/2
K080877 · Unilife Medical Solutions Limited · Oct 2008
ULTIMED ULTICARE SAFETY SYRINGE
K080600 · Ultimed, Inc. · Jun 2008
JIERUI SYRINGES AND NEEDLES
K072739 · Shandong Weigao Group Medical Polymer Co., Ltd. · Mar 2008
HYPODERMIC NEEDLE-PRO SAFETY ALLERGY TRAY
K072482 · Smiths Medical Asd, Inc. · Nov 2007
CAREO SAFETY SYRINGE FOR U-100 INSULIN 0.5CC/ML
K072037 · Life-Shield Products, Inc. · Aug 2007
SSAFE PLUS DISPOSABLE SAFETY SYRINGE, 3 CC AND 5 CC
K070117 · Dolomite Biotech Sdn Bhd · Aug 2007
K073206 · NEEDLE-TRAP/NEEDLE SAFETY LABEL
Download PDF FDA Summary Schreiner Medipharm