Cleared Traditional

K230502 - Ear Pressure Relief Device(Model:ER813B) (FDA 510(k) Clearance)

K230502 · Ningbo Albert Novosino Co., Ltd. · Ear, Nose, Throat device
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Jun 2023
Decision
105d
Days
-
Risk

K230502 is an FDA 510(k) clearance for the Ear Pressure Relief Device(Model:ER813B). Classified as Device, Inflation, Middle Ear within the MJV classification (a niche ENT category for middle ear pressure regulation devices).

Submitted by Ningbo Albert Novosino Co., Ltd. (Yuyao, CN). The FDA issued a Cleared decision on June 9, 2023 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel. 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. Middle ear inflation devices represent a low-volume ENT category with limited predicate history - the 165-day review reflects the FDA's careful equivalence assessment for this specialized device type.

View all Ningbo Albert Novosino Co., Ltd. devices

Submission Details

510(k) Number K230502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2023
Decision Date June 09, 2023
Days to Decision 105 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
16d slower than avg
Panel avg: 89d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MJV Device, Inflation, Middle Ear
Device Class -

Regulatory Consultant

Shanghai CV Technology Co., Ltd.
Doris Dong

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.