Cleared Traditional

K861437 - QMED SYSTEM 2150

K861437 is the FDA 510(k) clearance for QMED SYSTEM 2150 by Qmed, Inc.. It is a Class 2 Cardiovascular device (product code DXG) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K861437 · Qmed, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1986
Decision
33d
Days
Class 2
Risk

K861437 is an FDA 510(k) clearance for the QMED SYSTEM 2150. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Qmed, Inc. (Portland, US). The FDA issued a Cleared decision on May 20, 1986 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - 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: 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 Qmed, Inc. devices

Submission Details

510(k) Number K861437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1986
Decision Date May 20, 1986
Days to Decision 33 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 125d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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 - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 80
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K861437.
MTC 6210A CARDIAC OUTPUT COMPUTER
K854371 · Nihon Kohden America, Inc. · Feb 1987
KONTRON SUPERMON CARDIAC OUTPUT MODULE 7263
K862261 · Kontron Instruments, Inc. · Feb 1987
2200I PHYSIOLOGICAL MONITOR
K863308 · Datascope Corp. · Jan 1987
ARRHYTHMIA REVIEW STATION
K854136 · Marquette Electronics, Inc. · Dec 1985
DESERET THERMODILUTION CARDIAC OUTPUT
K841967 · Parke-Davis Co. · Aug 1985
FUKUDA DENSHI EH-11
K834059 · Fukuda Denshi USA, Inc. · Jun 1985