Cleared Traditional

K833552 - TREND PROCESSOR OPTION FOR #515 NEONAT

K833552 is an FDA 510(k) clearance for TREND PROCESSOR OPTION FOR #515 NEONAT, manufactured by Ge Medical Systems Information Technologies. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 105-day FDA review.

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

FDA 510(k) Submission Details - K833552

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.

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 167
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K833552.
SERVOMED COMPACT MONITOR SMK 155-7/101
K832025 · Litton Medical Electronics · Mar 1984
SEVOMED COMPACT MONITOR SMK 154-
K832095 · Litton Medical Electronics · Mar 1984
PATIENT MONITOR 78534B
K840251 · Hewlett-Packard Co. · Feb 1984
PATIENT MONITOR CM 135
K831164 · Honeywell, Inc. · Dec 1983
SERVOMED COMPACT MONITOR SMK 154-8/101
K832021 · Litton Medical Electronics · Nov 1983
SERVOMED COMPACT MONITOR SMK 155-9
K832035 · Litton Medical Electronics · Nov 1983