Cleared Traditional

K931439 - OHMEDA MODEL 5330 ANESTHETIC MONITOR

K931439 is an FDA 510(k) clearance for OHMEDA MODEL 5330 ANESTHETIC MONITOR, manufactured by Ohmeda Medical. The device is a Class 2 Anesthesiology device with product code CBQ cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K931439 · Ohmeda Medical · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
211d
Days
Class 2
Risk

K931439 is an FDA 510(k) clearance for the OHMEDA MODEL 5330 ANESTHETIC MONITOR. Classified as Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) (product code CBQ), Class II - Special Controls.

Submitted by Ohmeda Medical (Louisville, US). The FDA issued a Cleared decision on October 19, 1993 after a review of 211 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. 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 Ohmeda Medical devices

FDA 510(k) Submission Details - K931439

510(k) Number K931439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1993
Decision Date October 19, 1993
Days to Decision 211 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
71d slower than avg
Panel avg: 140d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 17
Devices cleared under the same product code (CBQ) and FDA review panel - the closest regulatory comparables to K931439.
PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B
K040917 · Philips Medizin Systeme Boeblingen GmbH · Apr 2004
MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5
K994188 · Agilent Technologies, GmbH · May 2000
OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR
K962648 · Ohmeda Medical · Jan 1997
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