Cleared Traditional

K993410 - DATES-OHMEDA AESTIVA SMARTVENT MRI

K993410 is an FDA 510(k) clearance for DATES-OHMEDA AESTIVA SMARTVENT MRI, manufactured by Datex-Ohmeda, Inc.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K993410 · Datex-Ohmeda, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
196d
Days
Class 2
Risk

K993410 is an FDA 510(k) clearance for the DATES-OHMEDA AESTIVA SMARTVENT MRI. 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 April 25, 2000 after a review of 196 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 Datex-Ohmeda, Inc. devices

FDA 510(k) Submission Details - K993410

510(k) Number K993410 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1999
Decision Date April 25, 2000
Days to Decision 196 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
56d slower than avg
Panel avg: 140d · This submission: 196d
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 110
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K993410.
NARKOMED MRI , NM-MRI
K001488 · Draeger Medical, Inc. · Jun 2000
MODIFICATION TO KION ANESTHESIA SYSTEM
K001315 · Siemens Elema AB · May 2000
DATEX-OHMEDA AESTIVA/5 WITH 7100 VENTILATOR
K000706 · Datex-Ohmeda, Inc. · May 2000
KION ANESTHESIA SYSTEM
K973971 · Siemens Medical Solutions USA, Inc. · Sep 1999
JULIAN ANESTHESIA WORKSTATION, MODEL # JULIAN
K983635 · Draeger Medical, Inc. · Jan 1999
SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM
K981530 · Spacelabs Medical, Inc. · Nov 1998