Cleared Traditional

K991376 - DAHEDI INSULIN INFUSION PUMP

K991376 is an FDA 510(k) clearance for DAHEDI 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 55-day FDA review.

K991376 · Disetronic Medical Systems · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
55d
Days
Class 2
Risk

K991376 is an FDA 510(k) clearance for the DAHEDI INSULIN INFUSION PUMP. Classified as Pump, Infusion, Insulin (product code LZG), Class II - Special Controls.

Submitted by Disetronic Medical Systems (Fort Myers, US). The FDA issued a Cleared decision on June 15, 1999 after a review of 55 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 - K991376

510(k) Number K991376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1999
Decision Date June 15, 1999
Days to Decision 55 days
Submission Type Traditional
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
74d faster than avg
Panel avg: 129d · This submission: 55d
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 K991376.
DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333
K032164 · Medtronic Minimed · Oct 2003
DISETRONIC D-TRON INSULIN INFUSION PUMP
K994186 · Disetronic Medical Systems · Dec 1999
MINIMED COM-STATION, HARDWARE-7301
K993012 · Medtronic Minimed · Nov 1999
MINIMED 508 INSULIN PUMP
K990801 · Medtronic Minimed · Jun 1999
DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP
K973044 · Disetronic Medical Systems · Sep 1997
MINIMED INFUSION PUMP, MODEL 507C
K972107 · Medtronic Minimed · Aug 1997