Cleared Traditional

K933420 - BREATHING TUBE SUPPORT

K933420 is an FDA 510(k) clearance for BREATHING TUBE SUPPORT, manufactured by Blake Medical, Inc.. The device is a Class 1 Anesthesiology device with product code CBH cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K933420 · Blake Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
92d
Days
Class 1
Risk

K933420 is an FDA 510(k) clearance for the BREATHING TUBE SUPPORT. Classified as Device, Fixation, Tracheal Tube (product code CBH), Class I - General Controls.

Submitted by Blake Medical, Inc. (Tifton, US). The FDA issued a Cleared decision on October 13, 1993 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5770 - 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 Blake Medical, Inc. devices

FDA 510(k) Submission Details - K933420

510(k) Number K933420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1993
Decision Date October 13, 1993
Days to Decision 92 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
48d faster than avg
Panel avg: 140d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

CBH Device Classification - Class 1, General Controls

Product Code CBH Device, Fixation, Tracheal Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5770
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 - CBH Device, Fixation, Tracheal Tube

All 23
Devices cleared under the same product code (CBH) and FDA review panel - the closest regulatory comparables to K933420.
DALE ENDOTRACHEAL TUBE HOLDER 270/280
K964399 · Dale Medical Products, Inc. · Jan 1997
FLEX BLUE
K950318 · King Systems Corp. · Feb 1995
STABILTRACH
K935171 · B&B Medical Technologies, Inc. · Dec 1993
ADHESIVE E.T. TAPE
K925386 · B&B Medical Technologies, Inc. · Apr 1993
ENDO TRACHEA TUBE FIXATION
K924551 · M. Imonti and Associates Inc., · Dec 1992
AGA TRACH TIES
K922657 · Aga Medical Products, Inc. · Jul 1992