Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ADULT & PEDIATRIC TRACHEOSTOMY MASKS

K-Number: K810946 · 1981-06-02

ApplicantAirlife, Inc.
Decision Date1981-06-02
Product CodeBYF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ADULT & PEDIATRIC TRACHEOSTOMY MASKS is the device name listed in this FDA 510(k) record. The listed applicant is Airlife, Inc.. It received FDA 510(k) clearance on 1981-06-02 under 510(k) number K810946. The device is classified under product code BYF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADULT & PEDIATRIC TRACHEOSTOMY MASKS?

ADULT & PEDIATRIC TRACHEOSTOMY MASKS is a medical device that received FDA 510(k) clearance on 1981-06-02. The listed applicant is Airlife, Inc.. The 510(k) number is K810946.

When did ADULT & PEDIATRIC TRACHEOSTOMY MASKS receive FDA 510(k) clearance?

ADULT & PEDIATRIC TRACHEOSTOMY MASKS received FDA 510(k) clearance on 1981-06-02, under 510(k) number K810946.

Who is the listed applicant for ADULT & PEDIATRIC TRACHEOSTOMY MASKS?

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

What is the FDA product code for ADULT & PEDIATRIC TRACHEOSTOMY MASKS?

The FDA product code for ADULT & PEDIATRIC TRACHEOSTOMY MASKS is BYF.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Airlife, 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.

K834573AQUA TRAPK834570VOLUME VENTILATOR CIRCUIT W/WATER TRAPK834077SINGLE USE NEBULIZER-ADJUST-AIR ENTRAINK833196VOLUME VENTILATOR CIRCUIT-NEBULIZERK833197TRACH SWIVE/CONNECTORK832725DUAL DIAL VENTURI STYLE MASK

View all 76 devices →

Related Devices (Code: BYF)

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.

K955483TRACH MASK MODEL (245, 246)Hospitak, Inc.K951652VENTIMASK MK IVFlexicare Medical, Ltd.K894457CARNATION TRACHEOSTOMY MASKSDadsun Corp., Ltd.K860873VENTURI MASK/ADULT & PAEDIATRICDhd Medical Products Div. Diemolding Corp.K860874VENTURI MASK W/HUMDIFICATION CUP ADULT/PAEDIATRICDhd Medical Products Div. Diemolding Corp.K852618OXY-DIALAshai Co. , Ltd.

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.

↑