Preceptis Medical
Developer of the Hummingbird tympanostomy tube system for pediatric ear-tube placement.
Company overview
Preceptis Medical develops technology for pediatric tympanostomy tube placement. Its Hummingbird system is offered to ENT practices as an option for in-office ear-tube procedures in appropriately selected children, with the company identifying use in patients six months and older.
The company lists its office in Golden Valley, Minnesota, and identifies David Carey as CEO and Greg Mielke as Chief Commercial Officer. Commercial adoption depends on clinician training, patient selection, office workflow and payment arrangements, not simply device availability.
FDA records document multiple Hummingbird decisions, including the 2015 system clearance, a separate tube record and a 2020 system decision. Company-hosted clinical evidence covers tolerability and procedural performance; results and selection criteria should be evaluated in the underlying studies. In-office treatment is not assumed appropriate for every child.
Leadership
3 peopleProducts & regulatory status How does MedTechIndex get this information?
Summary
The Hummingbird tympanostomy system has a 510(k) lineage including K221254, missing from the earlier snapshot. Its labeled office-use age and procedural limits remain important. The older Preceptis tube-inserter decision is recorded separately from the current branded configuration. [16][12][14][6][18][15][1]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [10][8]
Regulatory snapshot How to read this snapshot
U.S. FDA- 4
- 510(k) clearances
- 0
- De Novo grants
- 0
- PMA approvals
- 0
- Recall events
Latest recorded source review: 2026-10-20.
Commercial portfolio snapshot
Documented commercial product families.
Commercial development
Commercial development centers on ENT practice adoption and office-based procedure delivery. Broader use remains subject to device labeling and individual clinical judgment. [17][18]
Activity & Milestones
1 eventsHummingbird system FDA clearance
FDA recorded a substantially equivalent decision for K200952. [14]
19 Cited Sources
Accessed 10/29/2026
19 Cited Sources
Accessed 10/29/2026