Cleared Traditional

K200952 - Hummingbird Tympanostomy Tube System

K200952 is an FDA 510(k) clearance for Hummingbird Tympanostomy Tube System, manufactured by Preceptis Medical, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K200952 · Preceptis Medical, Inc. · Ear, Nose, Throat device
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Jun 2020
Decision
57d
Days
Class 2
Risk

K200952 is an FDA 510(k) clearance for the Hummingbird Tympanostomy Tube System. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Preceptis Medical, Inc. (Maple Grove, US). The FDA issued a Cleared decision on June 5, 2020 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3880 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Preceptis Medical, Inc. devices

FDA 510(k) Submission Details - K200952

510(k) Number K200952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2020
Decision Date June 05, 2020
Days to Decision 57 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 89d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETD Device Classification - Class 2, Special Controls

Product Code ETD Tube, Tympanostomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3880
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETD Tube, Tympanostomy

All 68
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K200952.
Biowy Tym Tube (TT)
K233658 · Biowy Corporation · Feb 2024
Tympanostomy Tubes
K232059 · Grace Medical, Inc. · Nov 2023
Hummingbird Tympanostomy Tube System
K221254 · Preceptis Medical, Inc. · Jul 2022
Ventilation (Tympanostomy) Tubes
K151067 · Medtronic Xomed, Inc. · Jul 2015
ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM
K103595 · Acclarent, Inc. · Apr 2011
TYMPANOSTOMY TUBE
K082188 · Acclarent, Inc. · Sep 2008