Cleared Traditional

K832999 - RESPIRATION MONITOR

K832999 is an FDA 510(k) clearance for RESPIRATION MONITOR, manufactured by Litton Medical Electronics. The device is a Class 2 Anesthesiology device with product code FLS cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K832999 · Litton Medical Electronics · Anesthesiology device
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Feb 1984
Decision
179d
Days
Class 2
Risk

K832999 is an FDA 510(k) clearance for the RESPIRATION MONITOR. Classified as Monitor, Apnea, Facility Use (product code FLS), Class II - Special Controls.

Submitted by Litton Medical Electronics (Mchenry, US). The FDA issued a Cleared decision on February 13, 1984 after a review of 179 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Litton Medical Electronics devices

FDA 510(k) Submission Details - K832999

510(k) Number K832999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1983
Decision Date February 13, 1984
Days to Decision 179 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 140d · This submission: 179d
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

Devices cleared under the same product code (FLS) and FDA review panel - the closest regulatory comparables to K832999.
REMBRANDT SYSTEM
K962865 · Airsep Corp. · Oct 1996
RESPITRACE PLUS
K894973 · Hogan & Hartson · Oct 1989
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