Cleared Traditional

K961707 - TRACH-EZE CLOSED VENTILATION SUCTION SY...

K961707 is the FDA 510(k) clearance for TRACH-EZE CLOSED VENTILATION SUCTION SY... by Sorenson Critical Care. It is a Class 1 Anesthesiology device (product code BSY) cleared through the Traditional 510(k) pathway after a 313-day FDA review.

K961707 · Sorenson Critical Care · Anesthesiology device
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Mar 1997
Decision
313d
Days
Class 1
Risk

K961707 is an FDA 510(k) clearance for the TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Sorenson Critical Care (Salt Lake City, US). The FDA issued a Cleared decision on March 11, 1997 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Sorenson Critical Care devices

Submission Details

510(k) Number K961707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1996
Decision Date March 11, 1997
Days to Decision 313 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 140d · This submission: 313d
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.

Regulatory Peers - BSY Catheters, Suction, Tracheobronchial

All 14
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K961707.
ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM
K955831 · Sherwood Medical Co. · Mar 1996
CONNECTING TUBE
K951745 · Vital Signs, Inc. · May 1995
TRIGUARD(TM) SUCTION SYSTEM
K945950 · Vital Signs, Inc. · Dec 1994
ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM
K934723 · Sherwood Medical Co. · Nov 1993
ARGYLE ASPIR-FLEX SUCTION CATHETER
K925556 · Sherwood Medical Co. · Jul 1993
ARGYLE AERO-JET SUCTION CATHETER
K922148 · Sherwood Medical Co. · Dec 1992