Cleared Traditional

K811059 - PENTAX BRONCHOFIBERSCOPE #FB-15A

K811059 is the FDA 510(k) clearance for PENTAX BRONCHOFIBERSCOPE #FB-15A 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 40-day FDA review.

K811059 · Pentax Precision Instrument Corp. · Ear, Nose, Throat device
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May 1981
Decision
40d
Days
Class 2
Risk

K811059 is an FDA 510(k) clearance for the PENTAX BRONCHOFIBERSCOPE #FB-15A. 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 May 27, 1981 after a review of 40 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 K811059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1981
Decision Date May 27, 1981
Days to Decision 40 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
49d faster than avg
Panel avg: 89d · This submission: 40d
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 K811059.
VARIOUS TYPES OF LIGHT SOURCE HANDLES
K822257 · Kelleher Corp. · Oct 1982
PENTAX BRONCHOFIBERSCOPE #FB-19E
K822844 · Pentax Precision Instrument Corp. · Oct 1982
RIGID FIBEROPTIC ENDOSCOPES
K822180 · Kelleher Corp. · Aug 1982
MODEL FBS-1, FLEXIBLE BRONCHOSCOPE
K811181 · American Optical Corp. · May 1981
PENTAX BROCHOFIBERSCOPE MODEL FB-17D,
K792342 · Pentax Precision Instrument Corp. · Dec 1979
PENTEX BRONCHOFIBERSCOPE MODEL FB-17A
K792267 · Pentax Precision Instrument Corp. · Dec 1979