Cleared Traditional

K844834 - MACHIDA FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE FNS-1

K844834 is an FDA 510(k) clearance for MACHIDA FLEXIBLE NASOPHARYNGO-LARYNGOSC..., manufactured by Machida America, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EOQ cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K844834 · Machida America, Inc. · Ear, Nose, Throat device
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Jun 1985
Decision
181d
Days
Class 2
Risk

K844834 is an FDA 510(k) clearance for the MACHIDA FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE FNS-1. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Machida America, Inc. (Orangeburg, US). The FDA issued a Cleared decision on June 11, 1985 after a review of 181 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 Machida America, Inc. devices

FDA 510(k) Submission Details - K844834

510(k) Number K844834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1984
Decision Date June 11, 1985
Days to Decision 181 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 90d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EOQ Device Classification - Class 2, Special Controls

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 220
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K844834.
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
LARYNGOTELESCOPE CURVED MLC-1
K832449 · Pentax Precision Instrument Corp. · Sep 1983
BRONCHO FIBERSCOPE FB-19C
K832492 · Pentax Precision Instrument Corp. · Sep 1983
BRONCHO-FIBERSCOPE
K832010 · KARL STORZ Endoscopy-America, Inc. · Aug 1983