Cleared Traditional

K930492 - IDACARE ANESTHESIA MANAGEMENT WORKSTATIN

K930492 is the FDA 510(k) clearance for IDACARE ANESTHESIA MANAGEMENT WORKSTATIN by Premier Anesthesia Systems. It is a Class 2 Anesthesiology device (product code BSZ) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K930492 · Premier Anesthesia Systems · Anesthesiology device
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Jun 1993
Decision
137d
Days
Class 2
Risk

K930492 is an FDA 510(k) clearance for the IDACARE ANESTHESIA MANAGEMENT WORKSTATIN. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Premier Anesthesia Systems (Washington, US). The FDA issued a Cleared decision on June 18, 1993 after a review of 137 days - within the typical 510(k) review window.

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. 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 Premier Anesthesia Systems devices

Submission Details

510(k) Number K930492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1993
Decision Date June 18, 1993
Days to Decision 137 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 140d · This submission: 137d
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 67
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K930492.
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