Cleared Traditional

K870857 - ABCOM 1 CARDIAC OUTPUT MONITOR

K870857 is an FDA 510(k) clearance for ABCOM 1 CARDIAC OUTPUT MONITOR, manufactured by Applied Biometrics, Inc.. The device is a Class 2 Cardiovascular device with product code JOP cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K870857 · Applied Biometrics, Inc. · Cardiovascular device
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Nov 1987
Decision
258d
Days
Class 2
Risk

K870857 is an FDA 510(k) clearance for the ABCOM 1 CARDIAC OUTPUT MONITOR. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Applied Biometrics, Inc. (Minnetonka, US). The FDA issued a Cleared decision on November 16, 1987 after a review of 258 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2880 - 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 Applied Biometrics, Inc. devices

FDA 510(k) Submission Details - K870857

510(k) Number K870857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1987
Decision Date November 16, 1987
Days to Decision 258 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 125d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOP Device Classification - Class 2, Special Controls

Product Code JOP Transducer, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2880
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 - JOP Transducer, Ultrasonic

All 55
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K870857.
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K871506 · Acuson Computed Sonography · Sep 1987