Cleared Traditional

K894755 - ASTRA DISPOSABLE SPRAY CANNULA (FDA 510(k) Clearance)

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

K894755 · Astra Pharmaceutical Products, Inc. · Anesthesiology device
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Jan 1990
Decision
169d
Days
Class 2
Risk

K894755 is an FDA 510(k) clearance for the ASTRA DISPOSABLE SPRAY CANNULA. Classified as Applicator (laryngo-tracheal), Topical Anesthesia (product code CCT), Class II - Special Controls.

Submitted by Astra Pharmaceutical Products, Inc. (Westborough, US). The FDA issued a Cleared decision on January 12, 1990 after a review of 169 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5170 - 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 Astra Pharmaceutical Products, Inc. devices

Submission Details

510(k) Number K894755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1989
Decision Date January 12, 1990
Days to Decision 169 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 139d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CCT Applicator (laryngo-tracheal), Topical Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5170
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.