Cleared Traditional

EXTENSION BOX EB200 (K834530) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K834530 · Honeywell, Inc. · Cardiovascular device
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Jun 1984
Decision
163d
Days
Class 2
Risk

K834530 is an FDA 510(k) clearance for the EXTENSION BOX EB200. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Honeywell, Inc. (Walker, US). The FDA issued a Cleared decision on June 1, 1984 after a review of 163 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 Honeywell, Inc. devices

Submission Details

510(k) Number K834530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1983
Decision Date June 01, 1984
Days to Decision 163 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 125d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 68
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K834530.
LIFESCOPE II
K841499 · Nihon Kohden America, Inc. · Aug 1984
LIFESCOPE 6 OEC-6102
K841501 · Nihon Kohden America, Inc. · Aug 1984
LIFESCOPE 6 OEC-6105
K841502 · Nihon Kohden America, Inc. · Aug 1984
PATIENT MONITOR 78534B
K840251 · Hewlett-Packard Co. · Feb 1984
TREND PROCESSOR OPTION FOR #515 NEONAT
K833552 · Ge Medical Systems Information Technologies · Jan 1984
PATIENT MONITOR 788 33A
K831943 · Hewlett-Packard Co. · Oct 1983