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FDA 510(k)

Ponto 5 Mini; Ponto 5 Superpower

K-Number: K261142 · 2026-08-26

ApplicantOticon Medical AB
Decision Date2026-08-26
Product CodeMAH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Ponto 5 Mini; Ponto 5 Superpower is the device name listed in this FDA 510(k) record. The listed applicant is Oticon Medical AB. It received FDA 510(k) clearance on 2026-08-26 under 510(k) number K261142. The device is classified under product code MAH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ponto 5 Mini; Ponto 5 Superpower?

Ponto 5 Mini; Ponto 5 Superpower is a medical device that received FDA 510(k) clearance on 2026-08-26. The listed applicant is Oticon Medical AB. The 510(k) number is K261142.

When did Ponto 5 Mini; Ponto 5 Superpower receive FDA 510(k) clearance?

Ponto 5 Mini; Ponto 5 Superpower received FDA 510(k) clearance on 2026-08-26, under 510(k) number K261142.

Who is the listed applicant for Ponto 5 Mini; Ponto 5 Superpower?

The FDA 510(k) record lists Oticon Medical AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ponto 5 Mini; Ponto 5 Superpower?

The FDA product code for Ponto 5 Mini; Ponto 5 Superpower is MAH.

Other records listing Oticon Medical AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240614Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHSK213733Ponto 5 SuperPowerK211640Ponto 5 MiniK203807Ponto Bone Anchored Hearing System, MONO Surgery KitK190540Ponto 4K161671Ponto 3, Ponto 3 Power and Ponto 3 SuperPower

View all 8 devices →

Related Devices (Code: MAH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K203807Ponto Bone Anchored Hearing System, MONO Surgery KitOticon Medical ABK182116BA310 Abutment, BIA310 Implant/AbutmentCochlear AmericasK152820Ponto Bone Anchored Hearing SystemOticon Medical AB

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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