Cleared Traditional

K905693 - H-TRON V 100 INSULIN INFUSION PUMP

K905693 is an FDA 510(k) clearance for H-TRON V 100 INSULIN INFUSION PUMP, manufactured by Disetronic Medical Systems. The device is a Class 2 General Hospital device with product code LZG cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K905693 · Disetronic Medical Systems · General Hospital
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Apr 1991
Decision
114d
Days
Class 2
Risk

K905693 is an FDA 510(k) clearance for the H-TRON V 100 INSULIN INFUSION PUMP. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Disetronic Medical Systems (Minnetonka, US). The FDA issued a Cleared decision on April 12, 1991 after a review of 114 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. 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 Disetronic Medical Systems devices

FDA 510(k) Submission Details - K905693

510(k) Number K905693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1990
Decision Date April 12, 1991
Days to Decision 114 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 129d · This submission: 114d
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 49
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K905693.
MINIMED INFUSION PUMP, MODEL 507C
K972107 · Medtronic Minimed · Aug 1997
MINIMED INSULIN PUMP, MODEL 505
K963948 · Medtronic Minimed · Apr 1997
MINIMED INFUSION PUMP, MODEL MMT-507
K960001 · Medtronic Minimed · Apr 1996
MINIMED(R) MODEL 506 EXTERNAL INSULIN PUMP
K901588 · Medtronic Minimed · Jul 1990
MODIFIED BETATRON IV INSULIN INFUSION SYSTEM
K900498 · Cardiac Pacemakers, Inc. · Feb 1990