Cleared Traditional

K982945 - DUAL PURPOSE CLOSED CATHETER (FDA 510(k) Clearance)

Class I Anesthesiology device.

K982945 · Spirit Medical Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
32d
Days
Class 1
Risk

K982945 is an FDA 510(k) clearance for the DUAL PURPOSE CLOSED CATHETER. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Spirit Medical Systems, Inc. (Parker, US). The FDA issued a Cleared decision on September 22, 1998 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6810 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Spirit Medical Systems, Inc. devices

Submission Details

510(k) Number K982945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1998
Decision Date September 22, 1998
Days to Decision 32 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
107d faster than avg
Panel avg: 139d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BSY Catheters, Suction, Tracheobronchial
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6810
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.