# K932166: Silicone Tympanostomy Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Richards, Inc.
- Decided: Jul 26, 1993 after 83 days
- Product code: ETD (Tube, Tympanostomy)
- Device class: 2
- Regulation: 21 CFR 874.3880
- Recalls of this device: 2 (0 Class I)
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Nov 19, 2024 · Class II · Z-0707-2025: Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent Silicone Ventilation Tubes.
- Dec 11, 2023 · Class II · Z-1004-2024: The expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly states the expiration date of February 12, 2033, for this lot

Source page: https://510kreport.com/device/K932166
Methodology: https://510kreport.com/methodology