Cleared Traditional

K220465 - PENTAX Medical EPK-3000 Imaging System ...

K220465 is the FDA 510(k) clearance for PENTAX Medical EPK-3000 Imaging System ... by Pentax of America, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EOB) cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K220465 · Pentax of America, Inc. · Ear, Nose, Throat device
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Nov 2022
Decision
272d
Days
Class 2
Risk

K220465 is an FDA 510(k) clearance for the PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medic.... Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Pentax of America, Inc. (Montvale, US). The FDA issued a Cleared decision on November 16, 2022 after a review of 272 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4760 - 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 of America, Inc. devices

Submission Details

510(k) Number K220465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2022
Decision Date November 16, 2022
Days to Decision 272 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
183d slower than avg
Panel avg: 89d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EOB Nasopharyngoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4760
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 - EOB Nasopharyngoscope (flexible Or Rigid)

All 86
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K220465.
Single-use Flexible Rhinolaryngoscope
K230536 · Hunan Vathin Medical Instrument Co., Ltd. · Jun 2023
RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
K221660 · Olympus Medical Systems Corp. · Dec 2022
Single-Use Flexible Rhinolaryngoscope
K221581 · Hunan Vathin Medical Instrument Co., Ltd. · Nov 2022
Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3
K221638 · Olympus Medical Systems Corp. · Sep 2022
ENT Nasopharyngoscope and Accessories
K214050 · Medimaging Integrated Solution, Inc (Miis) · Jul 2022
Zsquare ENT-Flex Endoscope
K220004 · Zsquare, Ltd. · Jun 2022