Cleared Traditional

K071097 - NAVIGATOR APPLICATIONS SUITE

K071097 is an FDA 510(k) clearance for NAVIGATOR APPLICATIONS SUITE, manufactured by GE Healthcare Finland Oy. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K071097 · GE Healthcare Finland Oy · Anesthesiology device
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Oct 2007
Decision
175d
Days
Class 2
Risk

K071097 is an FDA 510(k) clearance for the NAVIGATOR APPLICATIONS SUITE. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by GE Healthcare Finland Oy (Madison, US). The FDA issued a Cleared decision on October 10, 2007 after a review of 175 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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 GE Healthcare Finland Oy devices

FDA 510(k) Submission Details - K071097

510(k) Number K071097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2007
Decision Date October 10, 2007
Days to Decision 175 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 140d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSZ Device Classification - Class 2, Special Controls

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 153
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K071097.
NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01
K080175 · Datascope Corp., Patient Monitoring Division · Jun 2008
GE DATEX-OHMEDA AISYS
K073707 · Datex-Ohmeda, Inc. · Jan 2008
MAGELLAN-2200, MODEL-3 ANESTHESIA MACHINE
K072420 · Oceanic Medical Products, Inc. · Jan 2008
GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM
K071142 · Datex-Ohmeda · Jun 2007
ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM
K062388 · Docusys · Feb 2007
DIGITAL MXR-D FLOWMETER
K062155 · Porter Instrument Co., Inc. · Nov 2006