Cleared Traditional

K031065 - SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5

K031065 is an FDA 510(k) clearance for SYRINGEX SAFETY SYRINGE, manufactured by Syringex Medical, Inc.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K031065 · Syringex Medical, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
81d
Days
Class 2
Risk

K031065 is an FDA 510(k) clearance for the SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Syringex Medical, Inc. (Draper, US). The FDA issued a Cleared decision on June 23, 2003 after a review of 81 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 - K031065

510(k) Number K031065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2003
Decision Date June 23, 2003
Days to Decision 81 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
48d faster than avg
Panel avg: 129d · This submission: 81d
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 K031065.
INVIRO SNAP SAFETY SYRINGE, 1CC, 3CC, 5CC, AND 10CC
K032780 · Inviro Medical · Sep 2003
SAFEPRO PLUS SAFETY SYRINGE
K031830 · Formosa Medical Devices, Inc. · Aug 2003
SEZ SAFETY SYRINGE
K031163 · Sez Corporation · Jul 2003
BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY
K031594 · M.K. Meditech Co. , Ltd. · Jun 2003
CAREO RETRACTABLE SAFETY SYRINGE
K030976 · Life-Shield Products, Inc. · May 2003
TMD 1ML SAFETY SYRINGE (FA11 SERIES 1ML/FA51 SERIES U-100 INSULIN/FA71 SERIES TUBERCULIN)
K031062 · Taiject Medical Device Co., Ltd. · May 2003
K031065 · SYRINGEX SAFETY SYRINGE, MODEL 0322G1.5
Download PDF FDA Summary Syringex Medical, Inc.