# K103595: Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Acclarent, Inc.
- Decided: Apr 1, 2011 after 114 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: 2 generations back to K830228 (1983). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 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.
- K082188: Tympanostomy Tube, Acclarent, Inc. (2008) Summary page 1.
- K980828: Exmoor Myringotomy Kit, Exmoor Plastics, Ltd. (1998) Summary page 1.

## Most influential descendants
- K171239: TULA Tube Delivery System (2017), 0 descendants of its own

## Indications for use
The Tympanostomy Tube Delivery System is intended to provide a means to create a myringotomy with insertion of a preloaded Paparella type tympanostomy tube. Conditions for which tympanostomy tubes are indicated include: Chronic otitis media with effusion (serous, mucoid, or purulent) Recurrent otitis media that fails to respond to conventional medical treatment A history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus. Retraction pocket of the tympanic membrane.

Source page: https://510kreport.com/device/K103595
Methodology: https://510kreport.com/methodology