Cleared Traditional

K903135 - CLINI-CALC

K903135 is the FDA 510(k) clearance for CLINI-CALC by Shasta Logic Corp.. It is a Class 2 Anesthesiology device (product code BSZ) cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K903135 · Shasta Logic Corp. · Anesthesiology device
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Jan 1991
Decision
181d
Days
Class 2
Risk

K903135 is an FDA 510(k) clearance for the CLINI-CALC. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Shasta Logic Corp. (Redding, US). The FDA issued a Cleared decision on January 14, 1991 after a review of 181 days - an extended review cycle.

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 Shasta Logic Corp. devices

Submission Details

510(k) Number K903135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1990
Decision Date January 14, 1991
Days to Decision 181 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 140d · This submission: 181d
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 K903135.
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K901119 · Ohmeda Medical · May 1990