# K911580: Donaldson/Shepards DR/Collar/Shah Vent-Mini Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Exmoor Plastics, Ltd.
- Decided: Sep 24, 1991 after 174 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K171239: TULA Tube Delivery System (2017), 0 descendants of its own

Source page: https://510kreport.com/device/K911580
Methodology: https://510kreport.com/methodology