Cleared Traditional

K020655 - DELTEC INSULIN INFUSION PUMP AND ACCESS...

K020655 is an FDA 510(k) clearance for DELTEC INSULIN INFUSION PUMP AND ACCESS..., manufactured by Deltec, Inc.. The device is a Class 2 General Hospital device with product code LZG cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K020655 · Deltec, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
165d
Days
Class 2
Risk

K020655 is an FDA 510(k) clearance for the DELTEC INSULIN INFUSION PUMP AND ACCESSORIES. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on August 13, 2002 after a review of 165 days - an extended review cycle.

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 Deltec, Inc. devices

FDA 510(k) Submission Details - K020655

510(k) Number K020655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2002
Decision Date August 13, 2002
Days to Decision 165 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
36d slower than avg
Panel avg: 129d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 30
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K020655.
MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP
K041318 · Medtronic Minimed · Jul 2004
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715
K040676 · Medtronic Minimed · May 2004
DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333
K032164 · Medtronic Minimed · Oct 2003
MINIMED COM-STATION, HARDWARE-7301
K993012 · Medtronic Minimed · Nov 1999
MINIMED 508 INSULIN PUMP
K990801 · Medtronic Minimed · Jun 1999
MINIMED INFUSION PUMP, MODEL 507C
K972107 · Medtronic Minimed · Aug 1997