# K061058: Neozoline Ventilation Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Adept Medical, Ltd.
- Decided: Jul 12, 2006 after 86 days
- Product code: ETD (Tube, Tympanostomy)
- Device class: 2
- Regulation: 21 CFR 874.3880
- Recalls of this device: 7 (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’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Nov 24, 2024 · Class II · Z-0968-2025: Lack of 510(k) clearance.
- Nov 24, 2024 · Class II · Z-0969-2025: Lack of 510(k) clearance.
- Nov 24, 2024 · Class II · Z-0965-2025: Lack of 510(k) clearance.
- Nov 24, 2024 · Class II · Z-0966-2025: Lack of 510(k) clearance.
- Nov 24, 2024 · Class II · Z-0967-2025: Lack of 510(k) clearance.
- Nov 24, 2024 · Class II · Z-0963-2025: Lack of 510(k) clearance.
- Nov 24, 2024 · Class II · Z-0970-2025: Lack of 510(k) clearance.

## Indications for use
The largest patient population are children between 4 months and 6 years of age (but not exclusively). Otological ventilation tubes are indicated for patients with: - Chronic or recurrent otitis media with persistent effusion (OME). - Recurrent acute otitis media. - Acute otitis media with complications. - Eustachian tube dysfunction resulting in one or more of the following: significant and symptomatic hearing loss, otalgia, vertigo, and tinnitus. - Hearing loss resulting from bilateral chronic middle ear effusion.

Source page: https://510kreport.com/device/K061058
Methodology: https://510kreport.com/methodology