# K830228: Otological Ventilation Tubes-Various

- Pathway: 510(k) (Traditional)
- Applicant: Micromedics, Inc.
- Decided: Mar 7, 1983 after 42 days
- Product code: ETD (Tube, Tympanostomy)
- Device class: 2
- Regulation: 21 CFR 874.3880
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 5 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K082188: Tympanostomy Tube (2008), 2 descendants of its own
- K103595: Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System (2011), 1 descendant of its own
- K233658: Biowy Tym Tube (TT) (2024), 0 descendants of its own
- K232059: Tympanostomy Tubes (2023), 0 descendants of its own
- K171239: TULA Tube Delivery System (2017), 0 descendants of its own

## Recalls of this device
- May 12, 2014 · Class II · Z-1731-2014: One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. This poses no health hazard to the user or patie

Source page: https://510kreport.com/device/K830228
Methodology: https://510kreport.com/methodology