Cleared Traditional

K885085 - ERGOMED 840/ERGOMED 840L

K885085 is an FDA 510(k) clearance for ERGOMED 840/ERGOMED 840L, manufactured by Burdick Corp.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K885085 · Burdick Corp. · Cardiovascular device
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Oct 1989
Decision
298d
Days
Class 2
Risk

K885085 is an FDA 510(k) clearance for the ERGOMED 840/ERGOMED 840L. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Burdick Corp. (Miltoon, US). The FDA issued a Cleared decision on October 3, 1989 after a review of 298 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Burdick Corp. devices

FDA 510(k) Submission Details - K885085

510(k) Number K885085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1988
Decision Date October 03, 1989
Days to Decision 298 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 125d · This submission: 298d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 166
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K885085.
MODEL M1175A/M1176A WITH ST SEGMENT MONITORING
K900032 · Hewlett-Packard Co. · Apr 1990
MAC-LAB CARDIAC CATHETERIZATION LABORATORY SYSTEM
K895801 · Marquette Electronics, Inc. · Apr 1990
CARDIOCAP(TM) CT-104 MONITOR
K897080 · Datex Division Instrumentarium Corp. · Mar 1990
MODEL DS-504 DYNASCOPE PATIENT MONITOR
K893405 · Fukuda Denshi USA, Inc. · Oct 1989
TYPE 9140 (SYSTEM ATHENA)
K894699 · S & W Medico Teknik · Oct 1989
TYPE PDU/CDU 9040 (SYSTEM ATHENA)
K894700 · S & W Medico Teknik · Oct 1989