Cleared Traditional

K053519 - SAFETY SYRINGE

K053519 is an FDA 510(k) clearance for SAFETY SYRINGE, manufactured by Wuxi Yushou Medical Applicances Co., Ltd.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K053519 · Wuxi Yushou Medical Applicances Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
235d
Days
Class 2
Risk

K053519 is an FDA 510(k) clearance for the SAFETY SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Wuxi Yushou Medical Applicances Co., Ltd. (Racine, US). The FDA issued a Cleared decision on August 11, 2006 after a review of 235 days - an extended review 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: 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 - K053519

510(k) Number K053519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2005
Decision Date August 11, 2006
Days to Decision 235 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
106d slower than avg
Panel avg: 129d · This submission: 235d
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 K053519.
OMI RETRACTABLE SAFTEY SYRINGE, VARIOUS
K060971 · Omi Manufacturing Pty., Ltd. · Oct 2006
MANUEL SAFTEY SYRINGE PARTS 1 & 2
K060772 · Medsafe Asa · Oct 2006
PORTEX NEEDLE-PRO EDGE SAFETY WITH SYRINGE, MODELS 432310, 432210, 432510, 432558
K061194 · Smiths Medical Asd, Inc. · 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
RITRACT SAFETY SYRINGE
K060002 · Ritract , Ltd. · Jun 2006
K053519 · SAFETY SYRINGE
Download PDF FDA Summary Wuxi Yushou Medical A…