Cleared Special

K211640 - Ponto 5 Mini (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K211640 · Oticon Medical AB · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
75d
Days
Class 2
Risk

K211640 is an FDA 510(k) clearance for the Ponto 5 Mini. Classified as Hearing Aid, Bone Conduction (product code LXB), Class II - Special Controls.

Submitted by Oticon Medical AB (Askim, SE). The FDA issued a Cleared decision on August 10, 2021 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3302 - the FDA ear, nose and throat device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Oticon Medical AB devices

Submission Details

510(k) Number K211640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2021
Decision Date August 10, 2021
Days to Decision 75 days
Submission Type Special
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
14d faster than avg
Panel avg: 89d · This submission: 75d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LXB Hearing Aid, Bone Conduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3302
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 - LXB Hearing Aid, Bone Conduction

All 48
Devices cleared under the same product code (LXB) and FDA review panel - the closest regulatory comparables to K211640.
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K202048 · Cochlear Americas · Feb 2021