Cleared Traditional

K960488 - NEO 2 LINE SUCTION SYSTEM

K960488 is the FDA 510(k) clearance for NEO 2 LINE SUCTION SYSTEM by Alcove Medical, Inc.. It is a Class 1 Anesthesiology device (product code BSY) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K960488 · Alcove Medical, Inc. · Anesthesiology device
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Apr 1996
Decision
85d
Days
Class 1
Risk

K960488 is an FDA 510(k) clearance for the NEO 2 LINE SUCTION SYSTEM. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Alcove Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on April 26, 1996 after a review of 85 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 Alcove Medical, Inc. devices

Submission Details

510(k) Number K960488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1996
Decision Date April 26, 1996
Days to Decision 85 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
55d faster than avg
Panel avg: 140d · This submission: 85d
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 K960488.
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