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

FDA 510(k)

AVEA disposable expiratory filter/water trap (11790)

K-Number: K251133 · 2025-05-08

ApplicantTelesair, Inc.
Decision Date2025-05-08
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AVEA disposable expiratory filter/water trap (11790) is a medical device manufactured by Telesair, Inc.. It received FDA 510(k) clearance on 2025-05-08 under approval number K251133. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVEA disposable expiratory filter/water trap (11790)?

AVEA disposable expiratory filter/water trap (11790) is a medical device that received FDA 510(k) clearance on 2025-05-08. It is manufactured by Telesair, Inc.. The 510(k) number is K251133.

When was AVEA disposable expiratory filter/water trap (11790) approved by the FDA?

AVEA disposable expiratory filter/water trap (11790) received FDA 510(k) clearance on 2025-05-08, under approval number K251133.

What company makes AVEA disposable expiratory filter/water trap (11790)?

AVEA disposable expiratory filter/water trap (11790) is manufactured by Telesair, Inc..

What is the FDA product code for AVEA disposable expiratory filter/water trap (11790)?

The FDA product code for AVEA disposable expiratory filter/water trap (11790) is CBK.

Related Clinical Trials

NCT06945952 Efficacy of the Ratio of Respiratory Rate to Diaphragm Thickening Fraction in Prediction of Successful Weaning ACTIVE_NOT_RECRUITING

Other Devices by Telesair, Inc.

K223863BONHAWA Respiratory Humidifier

Related Devices (Code: CBK)

K153046HAMILTON-MR1Hamilton Medical AG K152068Astral 100/150Resmed, Ltd. K143035Flight 60 VentilatorFlight Medical Innovations , Ltd. K151252Puritan Bennett 840 Series Ventilator SystemCovidien LP K162738Puritan Bennett 980 Ventilator SystemCovidien K170037Breathe Technologies Life2000™ Ventilation SystemBreathe Technologies

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.

↑