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FDA 510(k)

LungFlow Airway Catheter

K-Number: K254037 · 2026-07-10

ApplicantFree Flow Medical, Inc.
Decision Date2026-07-10
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LungFlow Airway Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Free Flow Medical, Inc.. It received FDA 510(k) clearance on 2026-07-10 under 510(k) number K254037. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LungFlow Airway Catheter?

LungFlow Airway Catheter is a medical device that received FDA 510(k) clearance on 2026-07-10. The listed applicant is Free Flow Medical, Inc.. The 510(k) number is K254037.

When did LungFlow Airway Catheter receive FDA 510(k) clearance?

LungFlow Airway Catheter received FDA 510(k) clearance on 2026-07-10, under 510(k) number K254037.

Who is the listed applicant for LungFlow Airway Catheter?

The FDA 510(k) record lists Free Flow Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LungFlow Airway Catheter?

The FDA product code for LungFlow Airway Catheter is EOQ.

Other records listing Free Flow Medical, Inc. 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.

K254040LungFlow Basket Catheter

Related Devices (Code: EOQ)

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.

K260382MONARCH™ Platform (MON-000008)Auris Health, Inc.K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm CorporationK260565SmartClip Delivery Catheter (ADR-1715)Elucent MedicalK252341EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-H190 ); EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-1TH190)Olympus Medical Systems Corp.K260420LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)MacroLux Medical Technology Co., Ltd.K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation

Official Source

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

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