Cleared Special

K122483 - PEARL DIABETES MANAGEMENT SYSTEM

K122483 is an FDA 510(k) clearance for PEARL DIABETES MANAGEMENT SYSTEM, manufactured by Asante Solutions, Inc.. The device is a Class 2 General Hospital device with product code LZG cleared through the Special 510(k) pathway after a 142-day FDA review.

K122483 · Asante Solutions, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
142d
Days
Class 2
Risk

K122483 is an FDA 510(k) clearance for the PEARL DIABETES MANAGEMENT SYSTEM. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Asante Solutions, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on January 3, 2013 after a review of 142 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 - K122483

510(k) Number K122483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2012
Decision Date January 03, 2013
Days to Decision 142 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
13d slower than avg
Panel avg: 129d · This submission: 142d
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 K122483.
T:SLIM INSULIN DELIVERY SYSTEM
K141758 · Tandem Diabetes Care, Inc. · Oct 2014
T:SLIM INSULIN DELIVERY SYSTEM
K133593 · Tandem Diabetes Care, Inc. · Mar 2014
OMNIPOD INSULIN MANAGEMENT SYSTEM
K131294 · Insulet Corporation · Aug 2013
OMNIPOD INSULIN MANAGMENT SYSTEM
K122953 · Insulet Corporation · Dec 2012
ACCU-CHECK COMBO SYSTEM
K111353 · Roche Diagnostics · Jul 2012
MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
K120206 · Medtronic Minimed · Mar 2012
K122483 · PEARL DIABETES MANAGEMENT SYSTEM
Download PDF FDA Summary Asante Solutions, Inc.