Cleared Traditional

K964369 - TRACH CARE SET WITH MICROBAN

K964369 is an FDA 510(k) clearance for TRACH CARE SET WITH MICROBAN, manufactured by Ballard Medical Products. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K964369 · Ballard Medical Products · Anesthesiology device
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Feb 1997
Decision
102d
Days
Class 1
Risk

K964369 is an FDA 510(k) clearance for the TRACH CARE SET WITH MICROBAN. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Ballard Medical Products (Draper, US). The FDA issued a Cleared decision on February 11, 1997 after a review of 102 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 Ballard Medical Products devices

FDA 510(k) Submission Details - K964369

510(k) Number K964369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1996
Decision Date February 11, 1997
Days to Decision 102 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 140d · This submission: 102d
Pathway characteristics
Predicate-based equivalence.

BSY Device Classification - Class 1, General Controls

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 53
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K964369.
AMBU HAND POWER SUCTION PUMP
K992902 · Ambu, Inc. · Oct 1999
HI-CARE CLOSED SUCTION SYSTEM
K972258 · Mallinckrodt Medical · Dec 1997
ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM
K955831 · Sherwood Medical Co. · Mar 1996
SUCTION CATHETER KIT, STERILE, SINGLE-USE
K951506 · Trinity Laboratories, Inc. · Jul 1995
CONNECTING TUBE
K951745 · Vital Signs, Inc. · May 1995
TRIGUARD(TM) SUCTION SYSTEM
K945950 · Vital Signs, Inc. · Dec 1994