Cleared Traditional

K933781 - ANTI-DISCONNECTION MECHANISM

K933781 is an FDA 510(k) clearance for ANTI-DISCONNECTION MECHANISM, manufactured by Hammer-Plane, Inc.. The device is a Class 1 Anesthesiology device with product code CBH cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K933781 · Hammer-Plane, Inc. · Anesthesiology device
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Sep 1993
Decision
49d
Days
Class 1
Risk

K933781 is an FDA 510(k) clearance for the ANTI-DISCONNECTION MECHANISM. Classified as Device, Fixation, Tracheal Tube (product code CBH), Class I - General Controls.

Submitted by Hammer-Plane, Inc. (Simi Valley, US). The FDA issued a Cleared decision on September 22, 1993 after a review of 49 days - a notably fast clearance cycle.

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: 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 Hammer-Plane, Inc. devices

FDA 510(k) Submission Details - K933781

510(k) Number K933781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1993
Decision Date September 22, 1993
Days to Decision 49 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
91d faster than avg
Panel avg: 140d · This submission: 49d
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 21
Devices cleared under the same product code (CBH) and FDA review panel - the closest regulatory comparables to K933781.
DALE ENDOTRACHEAL TUBE HOLDER 270/280
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FLEX BLUE
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STABILTRACH
K935171 · B&B Medical Technologies, Inc. · Dec 1993
ADHESIVE E.T. TAPE
K925386 · B&B Medical Technologies, Inc. · Apr 1993
E.T. TAPE II
K912884 · B&B Medical Technologies, Inc. · Jul 1991
SALTER LABS MODEL #1015
K903539 · Salter Labs · Dec 1990