Cleared Traditional

TREND PROCESSOR OPTION FOR #515 NEONAT (K833552) - FDA 510(k) Clearance

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

K833552 · Ge Medical Systems Information Technologies · Cardiovascular device
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Jan 1984
Decision
105d
Days
Class 2
Risk

K833552 is an FDA 510(k) clearance for the TREND PROCESSOR OPTION FOR #515 NEONAT. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Ge Medical Systems Information Technologies (Mchenry, US). The FDA issued a Cleared decision on January 27, 1984 after a review of 105 days - within the typical 510(k) review window.

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 Ge Medical Systems Information Technologies devices

Submission Details

510(k) Number K833552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1983
Decision Date January 27, 1984
Days to Decision 105 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
20d faster than avg
Panel avg: 125d · This submission: 105d
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 69
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K833552.
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
PATIENT MONITOR 788 33A
K831943 · Hewlett-Packard Co. · Oct 1983
PATIENT MONITOR #78832A
K831944 · Hewlett-Packard Co. · Oct 1983
PATIENT MONITOR #78353A
K831787 · Hewlett-Packard Co. · Sep 1983