Cleared Special

K000706 - DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR

K000706 is an FDA 510(k) clearance for DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR, manufactured by Datex-Ohmeda, Inc.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Special 510(k) pathway after a 70-day FDA review.

K000706 · Datex-Ohmeda, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
70d
Days
Class 2
Risk

K000706 is an FDA 510(k) clearance for the DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Datex-Ohmeda, Inc. (Madison, US). The FDA issued a Cleared decision on May 11, 2000 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Datex-Ohmeda, Inc. devices

FDA 510(k) Submission Details - K000706

510(k) Number K000706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2000
Decision Date May 11, 2000
Days to Decision 70 days
Submission Type Special
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
70d faster than avg
Panel avg: 140d · This submission: 70d
Pathway characteristics
Modification to existing cleared device.

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 110
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K000706.
NARKOMED MRI-2, MODEL NM-MRI-2
K003579 · Draeger Medical, Inc. · Jan 2001
NARKOMED MRI , NM-MRI
K001488 · Draeger Medical, Inc. · Jun 2000
MODIFICATION TO KION ANESTHESIA SYSTEM
K001315 · Siemens Elema AB · May 2000
DATES-OHMEDA AESTIVA SMARTVENT MRI
K993410 · Datex-Ohmeda, Inc. · Apr 2000
KION ANESTHESIA SYSTEM
K973971 · Siemens Medical Solutions USA, Inc. · Sep 1999
JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN
K983635 · Draeger Medical, Inc. · Jan 1999