Cleared Traditional

K934920 - VB-1830/VB-1530

K934920 is the FDA 510(k) clearance for VB-1830/VB-1530 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 103-day FDA review.

K934920 · Pentax Precision Instrument Corp. · Ear, Nose, Throat device
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Jan 1994
Decision
103d
Days
Class 2
Risk

K934920 is an FDA 510(k) clearance for the VB-1830/VB-1530, VIDEO BRONCHOSCOPE. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Pentax Precision Instrument Corp. (Orangeburg, US). The FDA issued a Cleared decision on January 26, 1994 after a review of 103 days - within the typical 510(k) review window.

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 Pentax Precision Instrument Corp. devices

Submission Details

510(k) Number K934920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1993
Decision Date January 26, 1994
Days to Decision 103 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 89d · This submission: 103d
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 K934920.
KARL STORZ BRONCHOSCOPE ACCESSORIES
K943700 · KARL STORZ Endoscopy-America, Inc. · Aug 1994
RICHARD ROD LENS LARYNGOSCOPE
K941264 · Smith & Nephew Richards, Inc. · Jul 1994
MILL-ROSE PROTECTED TRANSLARYNGOSCOPIC CATHETER
K940521 · Mill-Rose Laboratory · May 1994
MODIFIED BRONCHOSCOPE AND ACCESSORIES
K933433 · Fujinon, Inc. · Nov 1993
EVIS 200 SYSTEM
K931154 · Olympus Corp. · Oct 1993
MILL-ROSE PULMONARY FORCEPS
K922204 · Mill-Rose Laboratory · Jul 1993