Cleared Traditional

K955645 - CATH-GUIDE

K955645 is an FDA 510(k) clearance for CATH-GUIDE, manufactured by Hudson Respiratory Care, Inc.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K955645 · Hudson Respiratory Care, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
91d
Days
Class 1
Risk

K955645 is an FDA 510(k) clearance for the CATH-GUIDE. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Hudson Respiratory Care, Inc. (Mccordsville, US). The FDA issued a Cleared decision on March 12, 1996 after a review of 91 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 Hudson Respiratory Care, Inc. devices

FDA 510(k) Submission Details - K955645

510(k) Number K955645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1995
Decision Date March 12, 1996
Days to Decision 91 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 140d · This submission: 91d
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 67
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K955645.
AMSINO SUCTION CATHETER
K973199 · Amsino Intl., Inc. · Sep 1997
TRACH CARE SET WITH MICROBAN
K964369 · Ballard Medical Products · Feb 1997
ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM
K955831 · Sherwood Medical Co. · Mar 1996
REDI NURSE SYSTEM (RNS) STERILE WATER FOR IRRIGATION
K952395 · Contour Fabricators of Florida, Inc. · Aug 1995
REDI NURSE SYSTEM (RNS) STERILE 0.9% SODIUM CHLORIDE SOLUTION
K952396 · Contour Fabricators of Florida, Inc. · Aug 1995
SUCTION CATHETER KIT, STERILE, SINGLE-USE
K951506 · Trinity Laboratories, Inc. · Jul 1995