# K980828: Exmoor Myringotomy Kit

- Pathway: 510(k) (Traditional)
- Applicant: Exmoor Plastics, Ltd.
- Decided: Oct 22, 1998 after 233 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; 2 cite 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. The FDA summary names its predicate without a number.
- (no number) Richards Set-Op Myringotomy Kit: named in the summary without a submission number
- (no number) Exmoor Tympanocentesis Kit: named in the summary without a submission number

## 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
- K990366: Exmoor Suction Clearance Kit (1999), 0 descendants of its own

## Indications for use
Requirement for myringotomy, with or without the insertion of aural ventilation tube(s).

Source page: https://510kreport.com/device/K980828
Methodology: https://510kreport.com/methodology