Cleared Traditional

SAF-T-SYRINGE- 0.5 AND 1ML/CC (K063340) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K063340 · Safety Medical International, Incorporated · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
120d
Days
Class 2
Risk

K063340 is an FDA 510(k) clearance for the SAF-T-SYRINGE- 0.5 AND 1ML/CC. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Safety Medical International, Incorporated (Beverly, US). The FDA issued a Cleared decision on March 6, 2007 after a review of 120 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.

View all Safety Medical International, Incorporated devices

Submission Details

510(k) Number K063340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2006
Decision Date March 06, 2007
Days to Decision 120 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 129d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K063340.
PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)
K252098 · Methyl Co., Ltd. · Feb 2026
VaporShield
K250847 · Vault Paragon Group, Inc. · Dec 2025
SaviSafe Safety Device
K230287 · Suzhou Savicred Biotechnology Co., Ltd. · Nov 2023
Shina Syringe
K231165 · Shina Med Corporation · Oct 2023
Medline Safety Insulin and TB Syringes
K231907 · Medline Industries, LP · Oct 2023
Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110)
K223376 · Cardinal Health200, LLC · Jun 2023