Cleared Traditional

K850791 - MDI 2000 - PULSE GENERATOR

K850791 is an FDA 510(k) clearance for MDI 2000 - PULSE GENERATOR, manufactured by Micromedical Devices, Inc.. The device is a Class 2 Cardiovascular device with product code DRO cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K850791 · Micromedical Devices, Inc. · Cardiovascular device
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Jun 1985
Decision
113d
Days
Class 2
Risk

K850791 is an FDA 510(k) clearance for the MDI 2000 - PULSE GENERATOR. Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by Micromedical Devices, Inc. (Englewood, US). The FDA issued a Cleared decision on June 19, 1985 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5550 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Micromedical Devices, Inc. devices

FDA 510(k) Submission Details - K850791

510(k) Number K850791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1985
Decision Date June 19, 1985
Days to Decision 113 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 125d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRO Device Classification - Class 2, Special Controls

Product Code DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5550
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)

All 57
Devices cleared under the same product code (DRO) and FDA review panel - the closest regulatory comparables to K850791.
LIFEPAK 8 MODIFICATION
K853732 · Physio-Control Corp. · Dec 1985
EMERGIPACE - EXTERNAL PACEMAKER
K850812 · Life Science Instrumentation, Inc. · Nov 1985
PACEPAC
K852958 · Medical Data Electronics · Oct 1985
AMENDMENT LIFEPAK 200, NPN 046
K851247 · Physio-Control Corp. · Apr 1985
AMENDMENT LIFEPAK 100, NPN 045
K851248 · Physio-Control Corp. · Apr 1985
PACE*AID 10 A -PAD 10A- PACEMAKER OUTPUT DISPLAY &
K850596 · Cardiac Resucitator Corp. · Mar 1985