Cleared Abbreviated

K080175 - NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01

K080175 is an FDA 510(k) clearance for NAVIGATOR ANESTHESIA DELIVERY SYSTEM, manufactured by Datascope Corp., Patient Monitoring Division. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Abbreviated 510(k) pathway after a 137-day FDA review.

K080175 · Datascope Corp., Patient Monitoring Division · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2008
Decision
137d
Days
Class 2
Risk

K080175 is an FDA 510(k) clearance for the NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Datascope Corp., Patient Monitoring Division (Mahwh, US). The FDA issued a Cleared decision on June 9, 2008 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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 Datascope Corp., Patient Monitoring Division devices

FDA 510(k) Submission Details - K080175

510(k) Number K080175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2008
Decision Date June 09, 2008
Days to Decision 137 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
3d faster than avg
Panel avg: 140d · This submission: 137d
Pathway characteristics
Standards-based clearance path.

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 131
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K080175.
COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM
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K081844 · Datex-Ohmeda, Inc. · Aug 2008
NAVIGATOR APPLICATIONS SUITE
K081941 · GE Healthcare Finland Oy · Aug 2008
GE DATEX-OHMEDA AISYS
K073707 · Datex-Ohmeda, Inc. · Jan 2008
NAVIGATOR APPLICATIONS SUITE
K071097 · GE Healthcare Finland Oy · Oct 2007
GE DATEX-OHMEDA AVANCE ANESTHESIA SYSTEM
K071142 · Datex-Ohmeda · Jun 2007