Cleared Traditional

TRACH CARE CATHETER (K872621) - FDA 510(k) Clearance

Class I Anesthesiology device.

K872621 · Ballard Medical Products · Anesthesiology device
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Sep 1987
Decision
71d
Days
Class 1
Risk

K872621 is an FDA 510(k) clearance for the TRACH CARE CATHETER. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Ballard Medical Products (Midvale, US). The FDA issued a Cleared decision on September 15, 1987 after a review of 71 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 Ballard Medical Products devices

Submission Details

510(k) Number K872621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1987
Decision Date September 15, 1987
Days to Decision 71 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 140d · This submission: 71d
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 12
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K872621.
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
RADIATION STERILIZED SUCTION CATHETERS
K820109 · Travenol Laboratories, S.A. · Jan 1982