Cleared Traditional

K800164 - 413A NEONATAL MONITOR

K800164 is an FDA 510(k) clearance for 413A NEONATAL MONITOR, manufactured by Xerox Corp.. The device is a Class 2 Anesthesiology device with product code FLS cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K800164 · Xerox Corp. · Anesthesiology device
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Apr 1980
Decision
76d
Days
Class 2
Risk

K800164 is an FDA 510(k) clearance for the 413A NEONATAL MONITOR. Classified as Monitor, Apnea, Facility Use (product code FLS), Class II - Special Controls.

Submitted by Xerox Corp. (Walker, US). The FDA issued a Cleared decision on April 10, 1980 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2377 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Xerox Corp. devices

FDA 510(k) Submission Details - K800164

510(k) Number K800164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1980
Decision Date April 10, 1980
Days to Decision 76 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 140d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLS Device Classification - Class 2, Special Controls

Product Code FLS Monitor, Apnea, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2377
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - FLS Monitor, Apnea, Facility Use

All 9
Devices cleared under the same product code (FLS) and FDA review panel - the closest regulatory comparables to K800164.
RESPITRACE PLUS
K894973 · Hogan & Hartson · Oct 1989
RESPIRATION MONITOR
K832999 · Litton Medical Electronics · Feb 1984
CLINICAL DATA APNEA DETECTOR
K821721 · Clinical Data, Inc. · Jul 1982
INFUSION CONTROLLER, PARENTERAL
K781216 · National Patent Development Corp. · Aug 1978
RESPIRATION MONITOR
K760104 · Air-Shields, Inc. · Sep 1976