Cleared Traditional

K962865 - REMBRANDT SYSTEM

K962865 is an FDA 510(k) clearance for REMBRANDT SYSTEM, manufactured by Airsep Corp.. The device is a Class 2 Anesthesiology device with product code FLS cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K962865 · Airsep Corp. · Anesthesiology device
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Oct 1996
Decision
94d
Days
Class 2
Risk

K962865 is an FDA 510(k) clearance for the REMBRANDT SYSTEM. Classified as Monitor, Apnea, Facility Use (product code FLS), Class II - Special Controls.

Submitted by Airsep Corp. (Buffalo, US). The FDA issued a Cleared decision on October 25, 1996 after a review of 94 days - within the typical 510(k) review window.

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 Airsep Corp. devices

FDA 510(k) Submission Details - K962865

510(k) Number K962865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received July 23, 1996
Decision Date October 25, 1996
Days to Decision 94 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 140d · This submission: 94d
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 K962865.
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