Cleared Traditional

K896887 - TRACHAEL SUCTION SET

K896887 is the FDA 510(k) clearance for TRACHAEL SUCTION SET by Orion Life Systems, Inc.. It is a Class 1 Anesthesiology device (product code BSY) cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K896887 · Orion Life Systems, Inc. · Anesthesiology device
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Apr 1990
Decision
136d
Days
Class 1
Risk

K896887 is an FDA 510(k) clearance for the TRACHAEL SUCTION SET. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Orion Life Systems, Inc. (Wheeling, US). The FDA issued a Cleared decision on April 23, 1990 after a review of 136 days - within the typical 510(k) review window.

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. 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 Orion Life Systems, Inc. devices

Submission Details

510(k) Number K896887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1989
Decision Date April 23, 1990
Days to Decision 136 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 140d · This submission: 136d
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 K896887.
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
RESPIRONICS SUCTIONEASY
K882017 · Respironics, Inc. · Jul 1988
SUCTION CATHETER KIT
K843076 · Travenol Laboratories, S.A. · Nov 1984
ARGYLE SUCTION CATHETERS
K830709 · Sherwood Medical Co. · Mar 1983