Cleared Special

DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP (K023471) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K023471 · Disetronic Medical Systems AG · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
14d
Days
Class 2
Risk

K023471 is an FDA 510(k) clearance for the DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Disetronic Medical Systems AG (St. Paul, US). The FDA issued a Cleared decision on October 29, 2002 after a review of 14 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.

View all Disetronic Medical Systems AG devices

Submission Details

510(k) Number K023471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2002
Decision Date October 29, 2002
Days to Decision 14 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
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 K023471.
Pivot Insulin Delivery System
K253534 · Modular Medical · Apr 2026
Modular Medical MODD1 Insulin Delivery System
K240158 · Modular Medical, Inc. · Sep 2024
Extended Reservoir
K241622 · Medtronic Minimed · Jul 2024
Omnipod GO Insulin Delivery Device
K223372 · Insulet Corporation · Apr 2023
Extended Reservoir
K210714 · Medtronic Minimed, Inc. · Apr 2022
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
K211575 · Insulet Corporation · Aug 2021