Cleared Traditional

K926451 - DATASCOPE MULTINEX II

K926451 is an FDA 510(k) clearance for DATASCOPE MULTINEX II, manufactured by Datascope Corp.. The device is a Class 2 Anesthesiology device with product code CBQ cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K926451 · Datascope Corp. · Anesthesiology device
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Aug 1993
Decision
244d
Days
Class 2
Risk

K926451 is an FDA 510(k) clearance for the DATASCOPE MULTINEX II. Classified as Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) (product code CBQ), Class II - Special Controls.

Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on August 25, 1993 after a review of 244 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 Datascope Corp. devices

FDA 510(k) Submission Details - K926451

510(k) Number K926451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1992
Decision Date August 25, 1993
Days to Decision 244 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 140d · This submission: 244d
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 K926451.
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