# K973226: Tubingen Tympanic Ventilation Tube, Tympanic Ventilation Tubes with Ene/S, Diabolo Tympanic Ventilation Tube, Minimal T)

- Pathway: 510(k) (Traditional)
- Applicant: Heinz Kurz GmbH Medizintechnik
- Decided: Nov 4, 1997 after 69 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.
8 later devices descend from it; 1 cites it directly.
0 of 9 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) Hubbard Airplane Vent Tube: named in the summary without a submission number
- (no number) Tiny Tytan Vent Tube: named in the summary without a submission number
- (no number) Reuter Bobbin: named in the summary without a submission number
- (no number) Collar Button: named in the summary without a submission number
- (no number) Spoon Bobbin: named in the summary without a submission number
- (no number) Shah Type Tube: named in the summary without a submission number
- (no number) T-Tubes: named in the summary without a submission number
- (no number) Beveled Bobbin: named in the summary without a submission number
- (no number) Shepard Grommets: named in the summary without a submission number

## Most influential descendants
- K071150: Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015 074, 1015 076, 1015 075, 1015 077, W/ Retention Wire (2007), 7 descendants of its own
- K133921: Preceptis Tympanostomy Tube Inserter (2014), 6 descendants of its own
- K142282: Hummingbird (TM) Tympanostomy Tube System (TTS) (2015), 5 descendants of its own
- K200952: Hummingbird Tympanostomy Tube System (2020), 4 descendants of its own
- K221254: Hummingbird Tympanostomy Tube System (2022), 2 descendants of its own

## Indications for use
Tympanic tubes are inserted into the eardrum (myringotomy) for drainage and temporary ventilation of the middle ear subsequent to acute otitis media. Tympanic tubes with one or two eyes are designed to increase the retention time in the eardrum. The substantially shortened passage of the DIABOLO reduces the length of the internal hollow cylinder and the smooth surface of the gold seems to diminish the risk of luminal occlusion. Placement: The tubes are placed in the tympanic membrane to provide the means for drainage of any fluid buildup in the middle ear while creating an avenue for the passage of air to equalize pressure on either side of the drum. 1. Temporary ventilation of the middle ear in serous otitis media in adult patients. 2. In cases of narrow meatus, atrophic drum or post tympanoplasty tube dysfunction. Due to its tiny size {Diameter 0.6 mm), insertion after tympanoplasty considerably reduces the risk of permanent perforation of the tympanum. This tympanic ventilation tube, constructed of gold-plated stainless steel (1.4301), has been designed for temporary ventilation in special cases in which paracentesis alone is not sufficient, yet retention time of conventional tubes would be too long. The tube features a sharpened end that can be pushed through the tympanic membrane with alligator forceps without prior paracentesis. If the effusion is somewhat thicker than expected, an additional small paracentesis beside the tube is recommended, via which the mucous tympanum can easily be aspirated due to the pressure balance which is achieved through the ventilation tube. Should secretion encrustation occur, the MINIMAL Ventilation Tube can be replaced without the need for surface anaesthesia and without pain to the patient as it has no internal flange but is kept in position through tissue tension. Placement: Following surface anaesthesia, the tube is pushed through the tympanic membrane with alligator forceps without prior paracentesis.

Source page: https://510kreport.com/device/K973226
Methodology: https://510kreport.com/methodology