Cleared Traditional

K042487 - PROCEDUR SF SAFETY SYRINGE DEVICE

K042487 is an FDA 510(k) clearance for PROCEDUR SF SAFETY SYRINGE DEVICE, manufactured by Avanca Medical Devices, Inc.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K042487 · Avanca Medical Devices, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
130d
Days
Class 2
Risk

K042487 is an FDA 510(k) clearance for the PROCEDUR SF SAFETY SYRINGE DEVICE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Avanca Medical Devices, Inc. (Albuquerque, US). The FDA issued a Cleared decision on January 21, 2005 after a review of 130 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K042487

510(k) Number K042487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2004
Decision Date January 21, 2005
Days to Decision 130 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
1d slower than avg
Panel avg: 129d · This submission: 130d
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 K042487.
INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE
K050131 · M.K. Meditech Co. , Ltd. · Apr 2005
ICC INSULIN SAFEPRO SAFETY SYRINGE
K050134 · Formosa Medical Devices, Inc. · Apr 2005
YIXIN SAFETY SYRINGE
K042102 · Jiangxi Sanxin (Eversincere) Medical Devices Group · Mar 2005
BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML
K043038 · Biotop Technology Co., Ltd. · Dec 2004
TAMPER EVIDENT ULTRASAFE PASSIVE DELIVERY SYSTEM
K042712 · Safety Syringes, Inc. · Oct 2004
TMD 0.5ML SAFETY SYRINGE (FA18 SERIES 0.5ML/FA58 SERIES U-100 INSULIN/FA78 SERIES TUBERCULIN)
K042426 · Taiject Medical Device Co., Ltd. · Sep 2004
K042487 · PROCEDUR SF SAFETY SYRINGE DEVICE
Download PDF FDA Summary Avanca Medical Device…