# K963727: Hoffman H/a Coated Long-Term Ventilation Tube with Liner

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed
- Decided: Feb 11, 1997 after 148 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
Longest line of descent: 1 generation back to K900267 (1990). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K900267: Jahn Ventilation Tube, Smith & Nephew Richards, Inc. (1990) Summary page 2.
- (no number) Xomed Silverstein Permanent Aeration Tube (SPAT): named in the summary without a submission number
- (no number) Fluoroplastic/Titanium Ventilation Tubes: named in the summary without a submission number

## Most influential descendants
- K151067: Ventilation (Tympanostomy) Tubes (2015), 0 descendants of its own

## Indications for use
The Xomed Hoffman H/A Coated Long-Term Ventilation Tube with Liner is intended for prescription use only, as a means of communication of the outer and middle ear to provide long-term ventilation or drainage of the middle ear when inserted under the tympanic membrane.

Source page: https://510kreport.com/device/K963727
Methodology: https://510kreport.com/methodology