Cleared Special

K994186 - DISETRONIC D-TRON INSULIN INFUSION PUMP

K994186 is an FDA 510(k) clearance for DISETRONIC D-TRON INSULIN INFUSION PUMP, manufactured by Disetronic Medical Systems. The device is a Class 2 General Hospital device with product code LZG cleared through the Special 510(k) pathway after a 20-day FDA review.

K994186 · Disetronic Medical Systems · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
20d
Days
Class 2
Risk

K994186 is an FDA 510(k) clearance for the DISETRONIC D-TRON 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 December 30, 1999 after a review of 20 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.

FDA 510(k) Submission Details - K994186

510(k) Number K994186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1999
Decision Date December 30, 1999
Days to Decision 20 days
Submission Type Special
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
109d faster than avg
Panel avg: 129d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

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 83
Devices cleared under the same product code (LZG) and FDA review panel - the closest regulatory comparables to K994186.
MICROJET QUARK, MODEL U100 OR U40
K013807 · Cane S.R.L. · Dec 2001
DANA DIABECARE
K001604 · Sooil Development Co., Ltd. · Aug 2000
R1000 SERIES INSULIN PUMP
K993184 · Animas Corp. · Feb 2000
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
K994186 · DISETRONIC D-TRON INSULIN INFUSION PUMP
Download PDF FDA Summary Disetronic Medical Sy…