Cleared Traditional

K884638 - BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR

K884638 is an FDA 510(k) clearance for BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, manufactured by Instrumentation Industries, Inc.. The device is a Class 2 Anesthesiology device with product code BSK cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K884638 · Instrumentation Industries, Inc. · Anesthesiology device
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Nov 1988
Decision
16d
Days
Class 2
Risk

K884638 is an FDA 510(k) clearance for the BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR. Classified as Cuff, Tracheal Tube, Inflatable (product code BSK), Class II - Special Controls.

Submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on November 23, 1988 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5750 - 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.

FDA 510(k) Submission Details - K884638

510(k) Number K884638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1988
Decision Date November 23, 1988
Days to Decision 16 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 140d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSK Device Classification - Class 2, Special Controls

Product Code BSK Cuff, Tracheal Tube, Inflatable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5750
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BSK Cuff, Tracheal Tube, Inflatable

All 39
Devices cleared under the same product code (BSK) and FDA review panel - the closest regulatory comparables to K884638.
DIGITAL CUFF PV GAUGE
K900755 · International Medical Products, Inc. · Apr 1990
CUFF BARO GUARD OR CBG ABBREVIATED
K901255 · Nelson Engineering, Inc. · Mar 1990
ATTACHABLE LANZ (TENTATIVE)
K885216 · Mallinckroot, Inc. · Mar 1989
PRISTINE SPECIMEN TUBE AND INTRODUCER SYSTEM
K881514 · Hall Laboratories, Inc. · Jun 1988
CUFFCHECK
K881178 · Dhd Medical Products Div. Diemolding Corp. · Apr 1988
CBG CUFF MANOMETER
K873614 · Bio-Med Devices, Inc. · Jan 1988
K884638 · BE 410 ENDOTRACHEAL TUBE/TRACH TUBE, PILOT REPAIR
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