Cleared Traditional

K232435 - Rhinolaryngoscope system

K232435 is an FDA 510(k) clearance for Rhinolaryngoscope system, manufactured by Shenzhen HugeMed Medical Technical Development Co., Ltd.. The device is a Class 2 Ear, Nose, Throat device with product code EOB cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K232435 · Shenzhen HugeMed Medical Technical Development Co., Ltd. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Apr 2024
Decision
256d
Days
Class 2
Risk

K232435 is an FDA 510(k) clearance for the Rhinolaryngoscope system. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Shenzhen HugeMed Medical Technical Development Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 26, 2024 after a review of 256 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 Shenzhen HugeMed Medical Technical Development Co., Ltd. devices

FDA 510(k) Submission Details - K232435

510(k) Number K232435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2023
Decision Date April 26, 2024
Days to Decision 256 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
167d slower than avg
Panel avg: 89d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EOB Device Classification - Class 2, Special Controls

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 Consultant

Shenzhen Chonconn Medical Consulting Co., Ltd.
Yang Jie

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EOB Nasopharyngoscope (flexible Or Rigid)

All 105
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K232435.
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