# K973587: Exmoor Tympanocentesis Kit (TK/1)

- Pathway: 510(k) (Traditional)
- Applicant: Exmoor Plastics, Ltd.
- Decided: Jan 23, 1998 after 123 days
- Product code: JZF (Tube, Ear Suction)
- Device class: 1
- Regulation: 21 CFR 874.4420
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Xomed, Juhn Tym-Tap: named in the summary without a submission number
- (no number) Sherwood, Specimen Trap: named in the summary without a submission number
- (no number) Storz, Senturia Specimen Collectors: named in the summary without a submission number
- (no number) Storz, Alden-Senturia Specimen Collector: named in the summary without a submission number

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

## Indications for use
Requirement for aspiration and analysis of middle ear fluid from behind an intact tympanic membrane (ear drum)

Source page: https://510kreport.com/device/K973587
Methodology: https://510kreport.com/methodology