Cleared Traditional

K954197 - DISPOSABLE FLEX TUBE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K954197 · Engstrom Medical · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
50d
Days
Class 1
Risk

K954197 is an FDA 510(k) clearance for the DISPOSABLE FLEX TUBE. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Engstrom Medical (S-161 02 Bromma, SE). The FDA issued a Cleared decision on October 26, 1995 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5810 - 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 Engstrom Medical devices

Submission Details

510(k) Number K954197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1995
Decision Date October 26, 1995
Days to Decision 50 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
89d faster than avg
Panel avg: 139d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BZA Connector, Airway (extension)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5810
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.