Cleared Traditional

K900236 - ET-RESTRAINT CAT. # ER 4000

K900236 is an FDA 510(k) clearance for ET-RESTRAINT CAT. # ER 4000, manufactured by Ventlab Corp.. The device is a Class 1 Anesthesiology device with product code CBH cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K900236 · Ventlab Corp. · Anesthesiology device
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Feb 1990
Decision
16d
Days
Class 1
Risk

K900236 is an FDA 510(k) clearance for the ET-RESTRAINT CAT. # ER 4000. Classified as Device, Fixation, Tracheal Tube (product code CBH), Class I - General Controls.

Submitted by Ventlab Corp. (Hackensack, US). The FDA issued a Cleared decision on February 2, 1990 after a review of 16 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 Ventlab Corp. devices

FDA 510(k) Submission Details - K900236

510(k) Number K900236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1990
Decision Date February 02, 1990
Days to Decision 16 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 140d · This submission: 16d
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 18
Devices cleared under the same product code (CBH) and FDA review panel - the closest regulatory comparables to K900236.
BABY E.T. TAPE II
K900912 · B&B Medical Technologies, Inc. · Aug 1990
E.T. TAPE II
K902065 · B&B Medical Technologies, Inc. · Jul 1990
NASAL E.T. TAPE
K900787 · B&B Medical Technologies, Inc. · Mar 1990
RESPIRONIC'S INFANT SECUREEASY
K882079 · Respironics, Inc. · Aug 1988
TRAKEFIT TRACHEOSTOMY TUBE HOLDER
K872277 · Ackrad Laboratories · Jul 1987
BABY E.T. TAPE(TM)
K871560 · B&B Medical Technologies, Inc. · May 1987