Cleared Special

K063126 - DANA DIABECARE IIS

K063126 is an FDA 510(k) clearance for DANA DIABECARE IIS, manufactured by Sooil Development Co., Ltd.. The device is a Class 2 General Hospital device with product code LZG cleared through the Special 510(k) pathway after a 112-day FDA review.

K063126 · Sooil Development Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
112d
Days
Class 2
Risk

K063126 is an FDA 510(k) clearance for the DANA DIABECARE IIS. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Sooil Development Co., Ltd. (San Diego, US). The FDA issued a Cleared decision on February 2, 2007 after a review of 112 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K063126

510(k) Number K063126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2006
Decision Date February 02, 2007
Days to Decision 112 days
Submission Type Special
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
17d faster than avg
Panel avg: 129d · This submission: 112d
Pathway characteristics
Modification to existing cleared device.

LZG Device Classification - Class 2, Special Controls

Product Code LZG Pump, Infusion, Insulin
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 - LZG Pump, Infusion, Insulin

All 83
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K063126.
AVIATOR INSULIN PUMP
K071788 · Abbott Diabetes Care, Inc. · Jan 2008
AMIGO INSULIN PUMP
K071613 · Nipro Diabetes Systems, Inc. · Dec 2007
EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE
K063674 · Animas Corp. · Mar 2007
DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817
K062323 · Smiths Medical MD, Inc. · Nov 2006
ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001
K060876 · Disetronic Medical Systems AG · Jun 2006
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E
K053177 · Medtronic Minimed · Jan 2006
K063126 · DANA DIABECARE IIS
Download PDF FDA Summary Sooil Development Co.…