Cleared Traditional

K071418 - DANA 3CC SYRINGE INSULIN RESERVOIR

K071418 is an FDA 510(k) clearance for DANA 3CC SYRINGE INSULIN RESERVOIR, manufactured by Sooil Development Co., Ltd.. The device is a Class 2 General Hospital device with product code MRZ cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K071418 · Sooil Development Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
105d
Days
Class 2
Risk

K071418 is an FDA 510(k) clearance for the DANA 3CC SYRINGE INSULIN RESERVOIR. Classified as Accessories, Pump, Infusion (product code MRZ), Class II - Special Controls.

Submitted by Sooil Development Co., Ltd. (North Attleboro, US). The FDA issued a Cleared decision on September 4, 2007 after a review of 105 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Sooil Development Co., Ltd. devices

FDA 510(k) Submission Details - K071418

510(k) Number K071418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2007
Decision Date September 04, 2007
Days to Decision 105 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 129d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRZ Device Classification - Class 2, Special Controls

Product Code MRZ Accessories, Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - MRZ Accessories, Pump, Infusion

All 24
Devices cleared under the same product code (MRZ) and FDA review panel - the closest regulatory comparables to K071418.
CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE
K082783 · Smiths Medical MD, Inc. · Dec 2008
ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM
K080227 · Roche Diagnostics Corp. · May 2008
CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE-ADMINISTRATOR (21-6275), POINT OF CARE (21-6276)
K072955 · Smiths Medical MD, Inc. · Feb 2008
S.P.A.R STERILE AMBULATORY RESERVOIR
K990091 · Faulding Pharmaceutical Co. · Apr 1999
INFUTEST 2000 INFUSION DEVICE ANALYZER
K980165 · Datrend Systems, Inc. · Apr 1998
THE HARVARD LIBRARY
K970678 · Harvard Apparatus, Inc. · Jan 1998