Cleared Traditional

K833491 - ENDO BITE BLOCK

K833491 is an FDA 510(k) clearance for ENDO BITE BLOCK, manufactured by American Endoscopy, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code KTI cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K833491 · American Endoscopy, Inc. · Ear, Nose, Throat device
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Apr 1984
Decision
201d
Days
Class 2
Risk

K833491 is an FDA 510(k) clearance for the ENDO BITE BLOCK. Classified as Bronchoscope Accessory (product code KTI), Class II - Special Controls.

Submitted by American Endoscopy, Inc. (Walker, US). The FDA issued a Cleared decision on April 25, 1984 after a review of 201 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4680 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all American Endoscopy, Inc. devices

FDA 510(k) Submission Details - K833491

510(k) Number K833491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1983
Decision Date April 25, 1984
Days to Decision 201 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 90d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTI Device Classification - Class 2, Special Controls

Product Code KTI Bronchoscope Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - KTI Bronchoscope Accessory

All 32
Devices cleared under the same product code (KTI) and FDA review panel - the closest regulatory comparables to K833491.
Y-ADAPTER
K082174 · Asthmatx, Inc. · Oct 2008
CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350
K023337 · Boston Scientific Corp · Nov 2002
MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210
K020765 · Boston Scientific Corp · Apr 2002