Cleared Traditional

K122063 - INTELLISAVE AX700 ANESTHESIA SYSTEM (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K122063 · Philips Anesthesia Care · Anesthesiology device
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Aug 2013
Decision
385d
Days
Class 2
Risk

K122063 is an FDA 510(k) clearance for the INTELLISAVE AX700 ANESTHESIA SYSTEM. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Philips Anesthesia Care (Rodovre, DK). The FDA issued a Cleared decision on August 2, 2013 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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. Elevated predicate reliance profile. 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 Philips Anesthesia Care devices

Submission Details

510(k) Number K122063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2012
Decision Date August 02, 2013
Days to Decision 385 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
246d slower than avg
Panel avg: 139d · This submission: 385d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 186
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