Cleared Special

K994188 - MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5

K994188 is an FDA 510(k) clearance for MODIFICATION TO AGILENT TECHNOLOGIES AN..., manufactured by Agilent Technologies, GmbH. The device is a Class 2 Anesthesiology device with product code CBQ cleared through the Special 510(k) pathway after a 158-day FDA review.

K994188 · Agilent Technologies, GmbH · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
158d
Days
Class 2
Risk

K994188 is an FDA 510(k) clearance for the MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5. Classified as Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) (product code CBQ), Class II - Special Controls.

Submitted by Agilent Technologies, GmbH (Boeblingen, DE). The FDA issued a Cleared decision on May 19, 2000 after a review of 158 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1500 - 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K994188

510(k) Number K994188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1999
Decision Date May 19, 2000
Days to Decision 158 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
18d slower than avg
Panel avg: 140d · This submission: 158d
Pathway characteristics
Modification to existing cleared device.

CBQ Device Classification - Class 2, Special Controls

Product Code CBQ Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1500
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 - CBQ Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration)

All 21
Devices cleared under the same product code (CBQ) and FDA review panel - the closest regulatory comparables to K994188.
PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B
K040917 · Philips Medizin Systeme Boeblingen GmbH · Apr 2004
OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR
K962648 · Ohmeda Medical · Jan 1997
OHMEDA MODEL 5330 ANESTHETIC MONITOR
K931439 · Ohmeda Medical · Oct 1993
DATASCOPE MULTINEX II
K926451 · Datascope Corp. · Aug 1993
AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE
K923433 · Instrumentarium Corp. · Jul 1993
AS/3 COP MODULE
K922876 · Datex Division Instrumentarium Corp. · Jul 1993
K994188 · MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5
Download PDF FDA Summary Agilent Technologies,…