Cleared Traditional

K954197 - DISPOSABLE FLEX TUBE

K954197 is an FDA 510(k) clearance for DISPOSABLE FLEX TUBE, manufactured by Engstrom Medical. The device is a Class 1 Anesthesiology device with product code BZA cleared through the Traditional 510(k) pathway after a 50-day FDA review.

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

FDA 510(k) Submission Details - K954197

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
90d faster than avg
Panel avg: 140d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

BZA Device Classification - Class 1, General Controls

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.

Regulatory Peers - BZA Connector, Airway (extension)

All 59
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K954197.
TRACH-ASSIST
K083702 · Mergenet Medical · Mar 2009
SURELOC CIRCUIT CONNECTOR
K954383 · Polamedco, Inc. · Dec 1995
PRIMA, INC. VENTILATOR HOSES
K944532 · Prima, Inc. · Dec 1994
PRIMA, INC. CONNECTORS AND AIRWAY EXTENSIONS
K944534 · Prima, Inc. · Nov 1994
PRIMA, INC. GAS SAMPLING LINES AND CONNECTORS
K944535 · Prima, Inc. · Nov 1994
AIRWAY CONNECTOR WITH FLEX TUBE
K942392 · Mallinckrodt Medical · Aug 1994