Cleared Special

K022831 - MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP

K022831 is an FDA 510(k) clearance for MODIFICATION TO DISETRONIC D-TRONPLUS I..., manufactured by Disetronic Medical Systems AG. The device is a Class 2 General Hospital device with product code LZG cleared through the Special 510(k) pathway after a 16-day FDA review.

K022831 · Disetronic Medical Systems AG · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
16d
Days
Class 2
Risk

K022831 is an FDA 510(k) clearance for the MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Disetronic Medical Systems AG (Burgdorf, SE). The FDA issued a Cleared decision on September 11, 2002 after a review of 16 days - a notably fast clearance cycle.

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. 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.

FDA 510(k) Submission Details - K022831

510(k) Number K022831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2002
Decision Date September 11, 2002
Days to Decision 16 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
113d faster than avg
Panel avg: 129d · This submission: 16d
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 K022831.
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K030531 · Minimed, Inc. · Jun 2003
EZMANAGER PLUS
K022394 · Animas Corp. · Jun 2003
DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP
K023471 · Disetronic Medical Systems AG · Oct 2002
DELTEC INSULIN INFUSION PUMP AND ACCESSORIES
K020655 · Deltec, Inc. · Aug 2002
DISETRONIC D-TRON INSULIN INFUSION PUMP
K021725 · Disetronic Medical Systems AG · Aug 2002
DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS
K022317 · Sooil Development Co., Ltd. · Aug 2002
K022831 · MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP
Download PDF FDA Summary Disetronic Medical Sy…