Cleared Traditional

K855102 - MONARK 869 ERGOMETER

K855102 is an FDA 510(k) clearance for MONARK 869 ERGOMETER, manufactured by Equilibrated Bio Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DSP cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K855102 · Equilibrated Bio Systems, Inc. · Cardiovascular device
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May 1986
Decision
137d
Days
Class 2
Risk

K855102 is an FDA 510(k) clearance for the MONARK 869 ERGOMETER. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Equilibrated Bio Systems, Inc. (Melville, US). The FDA issued a Cleared decision on May 9, 1986 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3535 - 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 Equilibrated Bio Systems, Inc. devices

FDA 510(k) Submission Details - K855102

510(k) Number K855102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1985
Decision Date May 09, 1986
Days to Decision 137 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 slower than avg
Panel avg: 125d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSP Device Classification - Class 2, Special Controls

Product Code DSP System, Balloon, Intra-aortic And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3535
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 - DSP System, Balloon, Intra-aortic And Control

All 148
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K855102.
40CC PERCUTANEOUS FURL SINGLE INTRA-AORTIC BALLOON
K863185 · Aries Medical, Inc. · Jan 1987
SYSTEM 90 TRANSPORT
K863219 · Datascope Corp. · Jan 1987
NOVEMPERC DOUBLE LUMEN INTRA-AORTIC BALLOON
K860638 · Kontron Instruments, Inc. · Oct 1986
KONTRON INTRA-AORTIC BALLOON PUMP MODEL KAAT
K860427 · Kontron Instruments, Inc. · May 1986
INTRA-AORTIC BALLOON PUMP MODEL K2000
K853062 · Kontron Instruments, Inc. · Jan 1986
DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO
K850482 · Datascope Corp. · Aug 1985