# K082188: Tympanostomy Tube

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Sep 19, 2008 after 46 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
Longest line of descent: 1 generation back to K830228 (1983). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K830228: Otological Ventilation Tubes-Various, Micromedics, Inc. (1983) Summary page 1.
- K941407: Tympanostomy (Ventilation) Tube, Xomed-Treace, Inc. (1995) Summary page 1.
- K911580: Donaldson/Shepards DR/Collar/Shah Vent-Mini Tubes, Exmoor Plastics, Ltd. (1991) Summary page 1.

## Most influential descendants
- K103595: Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System (2011), 1 descendant of its own
- K171239: TULA Tube Delivery System (2017), 0 descendants of its own

## Indications for use
Conditions for which tympanostomy tubes are indicated include: o Chronic otitis media with effusion (serous, mucoid, or purulent) o Recurrent otitis media that fails to respond to conventional medical treatment o A history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus. o Retraction pocket of the tympanic membrane.

Source page: https://510kreport.com/device/K082188
Methodology: https://510kreport.com/methodology