Cleared Traditional

K945994 - DUAL PURPOSE CATHETER

K945994 is an FDA 510(k) clearance for DUAL PURPOSE CATHETER, manufactured by Universal Medical Products, Inc.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K945994 · Universal Medical Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
211d
Days
Class 1
Risk

K945994 is an FDA 510(k) clearance for the DUAL PURPOSE CATHETER. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Universal Medical Products, Inc. (New Brunswick, US). The FDA issued a Cleared decision on June 21, 1995 after a review of 211 days - an extended review 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: 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 Universal Medical Products, Inc. devices

FDA 510(k) Submission Details - K945994

510(k) Number K945994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1994
Decision Date June 21, 1995
Days to Decision 211 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
71d slower than avg
Panel avg: 140d · This submission: 211d
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 70
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K945994.
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
CONNECTING TUBE
K951745 · Vital Signs, Inc. · May 1995
TRIGUARD(TM) SUCTION SYSTEM
K945950 · Vital Signs, Inc. · Dec 1994
KENDALL MODU-VAC CLOSED SUCTION SYSTEM
K944251 · Kendall Healthcare Products Co. Div.Of Tyco Health · Sep 1994