Cleared Traditional

K935600 - TRACHEAL SUCTION CATHETER

K935600 is an FDA 510(k) clearance for TRACHEAL SUCTION CATHETER, manufactured by Puritas Health Care, Inc.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K935600 · Puritas Health Care, Inc. · Anesthesiology device
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May 1994
Decision
172d
Days
Class 1
Risk

K935600 is an FDA 510(k) clearance for the TRACHEAL SUCTION CATHETER. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Puritas Health Care, Inc. (New Milford, US). The FDA issued a Cleared decision on May 10, 1994 after a review of 172 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 Puritas Health Care, Inc. devices

FDA 510(k) Submission Details - K935600

510(k) Number K935600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received November 19, 1993
Decision Date May 10, 1994
Days to Decision 172 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
32d slower than avg
Panel avg: 140d · This submission: 172d
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 63
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K935600.
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
SUCTION SET, TRACHAEL
K935583 · Puritas Health Care, Inc. · Apr 1994
MULLY SUCTION STRAIGHT WITH FINGERTIP/WITH FUNNEL/WITH VACUTIP
K935553 · Puritas Health Care, Inc. · Jan 1994
ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM
K934723 · Sherwood Medical Co. · Nov 1993