Cleared Special

K013801 - ULTRASAFE DENTAL INJECTION SYSTEM

K013801 is the FDA 510(k) clearance for ULTRASAFE DENTAL INJECTION SYSTEM by Safety Syringes, Inc.. It is a Class 2 General Hospital device (product code MEG) cleared through the Special 510(k) pathway after a 28-day FDA review.

K013801 · Safety Syringes, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
28d
Days
Class 2
Risk

K013801 is an FDA 510(k) clearance for the ULTRASAFE DENTAL INJECTION SYSTEM. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Safety Syringes, Inc. (Carlsbad, US). The FDA issued a Cleared decision on December 13, 2001 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Safety Syringes, Inc. devices

Submission Details

510(k) Number K013801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2001
Decision Date December 13, 2001
Days to Decision 28 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 39
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K013801.
MEDLINE RETRACTABLE SAFETY SYRINGE
K101560 · Medline Industries, Inc. · Mar 2011
TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR
K051865 · Terumo Medical Corp. · Sep 2005
TERUMO SURGUARD SAFETY SYRINGE
K024249 · Terumo Medical Corp. · Feb 2003
BECTON DICKINSON SYRINGE
K992734 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1999
HYPO(R) SAFETY CARTRIDGE SYRINGE
K936040 · Smith & Nephew, Inc. · May 1995