Cleared Abbreviated

K011597 - SMARTMONITOR 2, MODEL 4000

K011597 is an FDA 510(k) clearance for SMARTMONITOR 2, manufactured by Respironics Georgia, Inc.. The device is a Class 2 Anesthesiology device with product code FLS cleared through the Abbreviated 510(k) pathway after a 232-day FDA review.

K011597 · Respironics Georgia, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
232d
Days
Class 2
Risk

K011597 is an FDA 510(k) clearance for the SMARTMONITOR 2, MODEL 4000. Classified as Monitor, Apnea, Facility Use (product code FLS), Class II - Special Controls.

Submitted by Respironics Georgia, Inc. (Kennesaw, US). The FDA issued a Cleared decision on January 11, 2002 after a review of 232 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Respironics Georgia, Inc. devices

FDA 510(k) Submission Details - K011597

510(k) Number K011597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2001
Decision Date January 11, 2002
Days to Decision 232 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 140d · This submission: 232d
Pathway characteristics
Standards-based clearance path.

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 8
Devices cleared under the same product code (FLS) and FDA review panel - the closest regulatory comparables to K011597.
HANNAH WIRELESS VITAL SIGNS MONITOR
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REMBRANDT SYSTEM
K962865 · Airsep Corp. · Oct 1996
PROPAQ ENCORE 200 SERIES MONITOR WITH NEONATAL MODE AND IMPEDANCE PNEUMOGRAPHY OPTIONS
K951246 · Protocol Systems, Inc. · Feb 1996
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