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FDA 510(k)

Orion

K-Number: K253553 · 2026-06-04

ApplicantResmed Corp
Decision Date2026-06-04
Product CodeBZD
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Orion is the device name listed in this FDA 510(k) record. The listed applicant is Resmed Corp. It received FDA 510(k) clearance on 2026-06-04 under 510(k) number K253553. 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 Orion?

Orion is a medical device that received FDA 510(k) clearance on 2026-06-04. The listed applicant is Resmed Corp. The 510(k) number is K253553.

When did Orion receive FDA 510(k) clearance?

Orion received FDA 510(k) clearance on 2026-06-04, under 510(k) number K253553.

Who is the listed applicant for Orion?

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 Orion?

The FDA product code for Orion 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.

K254104ResScan EssentialsK251889myAirK251657Personalized Therapy Comfort Settings (PTCS)K250624myAirK241939EasyCare 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.

K254104ResScan 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)K251847Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskSleepnet CorporationK253939DeltaWave Nasal Pillow SystemRemSleep Holdings, 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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