Cleared Traditional

K832449 - LARYNGOTELESCOPE CURVED MLC-1

K832449 is the FDA 510(k) clearance for LARYNGOTELESCOPE CURVED MLC-1 by Pentax Precision Instrument Corp.. It is a Class 2 Ear, Nose, Throat device (product code EOQ) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K832449 · Pentax Precision Instrument Corp. · Ear, Nose, Throat device
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Sep 1983
Decision
57d
Days
Class 2
Risk

K832449 is an FDA 510(k) clearance for the LARYNGOTELESCOPE CURVED MLC-1. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Pentax Precision Instrument Corp. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1983 after a review of 57 days - a notably fast clearance 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: 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 Pentax Precision Instrument Corp. devices

Submission Details

510(k) Number K832449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1983
Decision Date September 20, 1983
Days to Decision 57 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
32d faster than avg
Panel avg: 89d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EOQ Bronchoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. 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 - EOQ Bronchoscope (flexible Or Rigid)

All 185
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K832449.
BIOPSY FORCEPS
K895415 · Symbiosis Corp. · Oct 1989
CANNULATED BIOPSY FORCEPS
K892687 · Zinnanti Surgical Instruments, Inc. · Jun 1989
CO2 FIBEROPTIC DELIVERY SYSTEM/BRONCHOSCOPIC USE
K862835 · Cooper Lasersonics, Inc. · Feb 1987
BRONCHO FIBERSCOPE FB-19C
K832492 · Pentax Precision Instrument Corp. · Sep 1983
BRONCHO-FIBERSCOPE
K832010 · KARL STORZ Endoscopy-America, Inc. · Aug 1983
VARIOUS TYPES OF LIGHT SOURCE HANDLES
K822257 · Kelleher Corp. · Oct 1982