Cleared Traditional

PatCom Distal Chip Endoscope (K222587) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222587 · H&A Mui Enterprises, Inc. · Ear, Nose, Throat device
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Jul 2023
Decision
336d
Days
Class 2
Risk

K222587 is an FDA 510(k) clearance for the PatCom Distal Chip Endoscope. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by H&A Mui Enterprises, Inc. (Mississauga, CA). The FDA issued a Cleared decision on July 28, 2023 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 H&A Mui Enterprises, Inc. devices

Submission Details

510(k) Number K222587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2022
Decision Date July 28, 2023
Days to Decision 336 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
247d slower than avg
Panel avg: 89d · This submission: 336d
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 66
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K222587.
MonoStereo
K234096 · Medicaltek Co., Ltd. · Sep 2024
Rhinolaryngoscope system
K232435 · Shenzhen HugeMed Medical Technical Development Co., Ltd. · Apr 2024
ATMOS Scope (507.7000.0)
K232015 · Atmos Medizintechnik GmbH & Co. KG · Aug 2023
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