# K133921: Preceptis Tympanostomy Tube Inserter

- Pathway: 510(k) (Traditional)
- Applicant: Preceptis Medical
- Decided: Aug 22, 2014 after 242 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: 2 generations back to K973226 (1997). 2 ancestors in all.
6 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)
- K071150: Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015 074, 1015 076, 1015 075, 1015 077, W/ Retention Wire, Heinz Kurz GmbH Medizintechnik (2007) Summary page 4.

## Most influential descendants
- 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
- K232702: Solo+ Tympanostomy Tube Device (TTD) (2024), 1 descendant of its own
- K252436: Tula Tympanostomy Tube Delivery Device (2026), 0 descendants of its own

## Indications for use
The Tympanostomy Tube System is intended to deliver a tympanostomy tube in tympanostomy procedures in which the patient is receiving a tympanostomy tube.

Source page: https://510kreport.com/device/K133921
Methodology: https://510kreport.com/methodology