Cleared Traditional

K973044 - DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP

K973044 is an FDA 510(k) clearance for DISETRONIC H-TRON PLUS V 100 INSULIN IN..., 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 31-day FDA review.

K973044 · Disetronic Medical Systems · General Hospital
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Sep 1997
Decision
31d
Days
Class 2
Risk

K973044 is an FDA 510(k) clearance for the DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Disetronic Medical Systems (Minneapolis, US). The FDA issued a Cleared decision on September 15, 1997 after a review of 31 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Disetronic Medical Systems devices

FDA 510(k) Submission Details - K973044

510(k) Number K973044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received August 15, 1997
Decision Date September 15, 1997
Days to Decision 31 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
98d faster than avg
Panel avg: 129d · This submission: 31d
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 K973044.
MINIMED COM-STATION, HARDWARE-7301
K993012 · Medtronic Minimed · Nov 1999
DAHEDI INSULIN INFUSION PUMP
K991376 · Disetronic Medical Systems · Jun 1999
MINIMED 508 INSULIN PUMP
K990801 · Medtronic Minimed · Jun 1999
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