Cleared Traditional

K964961 - MODEL 405T WITH ETCO2 OPTION

K964961 is an FDA 510(k) clearance for MODEL 405T WITH ETCO2 OPTION, manufactured by Ivy Biomedical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CCK cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K964961 · Ivy Biomedical Systems, Inc. · Anesthesiology device
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May 1997
Decision
154d
Days
Class 2
Risk

K964961 is an FDA 510(k) clearance for the MODEL 405T WITH ETCO2 OPTION. Classified as Analyzer, Gas, Carbon-dioxide, Gaseous-phase (product code CCK), Class II - Special Controls.

Submitted by Ivy Biomedical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on May 14, 1997 after a review of 154 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1400 - 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 Ivy Biomedical Systems, Inc. devices

FDA 510(k) Submission Details - K964961

510(k) Number K964961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1996
Decision Date May 14, 1997
Days to Decision 154 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
14d slower than avg
Panel avg: 140d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCK Device Classification - Class 2, Special Controls

Product Code CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1400
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 - CCK Analyzer, Gas, Carbon-dioxide, Gaseous-phase

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