Class Class II

AVEA disposable expiratory filter/water trap (11790) (K251133)

K251133 2025-05-08 Traditional
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Description

AVEA disposable expiratory filter/water trap (11790) by Telesair, Inc., an FDA 510(k) cleared anesthesiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251133
Clearance Date2025-05-08
Clearance TypeTraditional
Product CodeCBK
Regulation Number868.5895

Categories

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Predicate lineage for K251133

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. AVEA disposable expiratory filter/water trap (11790) (K251133) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K081837AVEA VENTILATORCardinal Health 207, Inc.2008

Trace the full predicate network for K251133

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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