# K974007: Shah Permavent

- Pathway: 510(k) (Traditional)
- Applicant: Exmoor Plastics, Ltd.
- Decided: Dec 12, 1997 after 52 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.
No later device cites it as a predicate yet.
0 of 1 device 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 Shah Perma-vent Tube, Cat. No. 24-0012: named in the summary without a submission number
- (no number) Richards Per-Lee Drain Tube, Cat. No. 24-0026: named in the summary without a submission number
- (no number) Xomed-Treace Per-Lee Vent Tube, Cat. No. 10-25025: named in the summary without a submission number

## Indications for use
In the treatment of: 1. ofitis media with effusion (glue ear) 2. eustachian tube dysfunction 3. other condition requiring ventilation of the middle ear cleft, e.g. retraction pockets in the tympanic membrane, adhesive otitis media, where long-term ventilation is indicated.

Source page: https://510kreport.com/device/K974007
Methodology: https://510kreport.com/methodology