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FDA 510(k)

Personalized Therapy Comfort Settings (PTCS)

K-Number: K251657 · 2025-12-05

ApplicantResmed Corp
Decision Date2025-12-05
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Personalized Therapy Comfort Settings (PTCS) is the device name listed in this FDA 510(k) record. The listed applicant is Resmed Corp. It received FDA 510(k) clearance on 2025-12-05 under 510(k) number K251657. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Personalized Therapy Comfort Settings (PTCS)?

Personalized Therapy Comfort Settings (PTCS) is a medical device that received FDA 510(k) clearance on 2025-12-05. The listed applicant is Resmed Corp. The 510(k) number is K251657.

When did Personalized Therapy Comfort Settings (PTCS) receive FDA 510(k) clearance?

Personalized Therapy Comfort Settings (PTCS) received FDA 510(k) clearance on 2025-12-05, under 510(k) number K251657.

Who is the listed applicant for Personalized Therapy Comfort Settings (PTCS)?

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

What is the FDA product code for Personalized Therapy Comfort Settings (PTCS)?

The FDA product code for Personalized Therapy Comfort Settings (PTCS) is BZD.

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Other records listing Resmed Corp 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.

K253553OrionK254104ResScan EssentialsK251889myAirK250624myAirK241939EasyCare Tx 2K241216myAir

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Related Devices (Code: BZD)

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.

K253044RXiBreeze PAP System (RXiBreeze 20C)Resvent Medical Technology Co., Ltd.K253553OrionResmed CorpK254104ResScan EssentialsResmed CorpK251920Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face MaskDcstar, Inc.K253166F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BMC Medical Co., Ltd.K252338MySleepDashSomnetics International, Inc. (Dba Transcend Inc)

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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