Cleared Special

K990132 - DATEX-OHMEDA ANESTHESIA VAPORIZER

K990132 is an FDA 510(k) clearance for DATEX-OHMEDA ANESTHESIA VAPORIZER, manufactured by Datex-Ohmeda, Inc.. The device is a Class 2 Anesthesiology device with product code CAD cleared through the Special 510(k) pathway after a 7-day FDA review.

K990132 · Datex-Ohmeda, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
7d
Days
Class 2
Risk

K990132 is an FDA 510(k) clearance for the DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC. Classified as Vaporizer, Anesthesia, Non-heated (product code CAD), Class II - Special Controls.

Submitted by Datex-Ohmeda, Inc. (Madison, US). The FDA issued a Cleared decision on January 21, 1999 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5880 - 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 - K990132

510(k) Number K990132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1999
Decision Date January 21, 1999
Days to Decision 7 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
133d faster than avg
Panel avg: 140d · This submission: 7d
Pathway characteristics
Modification to existing cleared device.

CAD Device Classification - Class 2, Special Controls

Product Code CAD Vaporizer, Anesthesia, Non-heated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5880
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 - CAD Vaporizer, Anesthesia, Non-heated

All 24
Devices cleared under the same product code (CAD) and FDA review panel - the closest regulatory comparables to K990132.
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER
K012924 · Datex-Ohmeda, Inc. · Jan 2002
DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER
K002878 · Datex-Ohmeda, Inc. · Sep 2000
DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA
K000275 · Datex-Ohmeda, Inc. · Apr 2000
SIEMENS SEVOFLURANE VAPORIZER SV 953
K980884 · Siemens Medical Solutions USA, Inc. · Aug 1998
DRAGER-VAPOR 19.3
K981773 · Draeger Medical, Inc. · Jul 1998
DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS
K981472 · Draeger Medical, Inc. · May 1998