# K961873: Activent Antimicrobial Ventilation Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Xomed, Inc.
- Decided: Jul 1, 1996 after 47 days
- Product code: ETD (Tube, Tympanostomy)
- Device class: 2
- Regulation: 21 CFR 874.3880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Silicone ACTIVENT tubes: named in the summary without a submission number

## Indications for use
The intended use of the fluoroplastic antimicrobial vent tube is identical to the currently marketed silicone ACTIVENT tubes: for prescription use only, as a means of temporary communication of the outer and middle ear to provide ventilation or drainage of the middle ear when inserted through an incision in the tympanic membrane.

Source page: https://510kreport.com/device/K961873
Methodology: https://510kreport.com/methodology