Cleared Traditional

K151830 - Hummingbird Tympanostomy Tube

K151830 is an FDA 510(k) clearance for Hummingbird Tympanostomy Tube, manufactured by Preceptis Medical. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K151830 · Preceptis Medical · Ear, Nose, Throat device
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Sep 2015
Decision
77d
Days
Class 2
Risk

K151830 is an FDA 510(k) clearance for the Hummingbird Tympanostomy Tube. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Preceptis Medical (Plymouth, US). The FDA issued a Cleared decision on September 21, 2015 after a review of 77 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 devices

FDA 510(k) Submission Details - K151830

510(k) Number K151830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2015
Decision Date September 21, 2015
Days to Decision 77 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
13d faster than avg
Panel avg: 90d · This submission: 77d
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 89
Devices cleared under the same product code (ETD) and FDA review panel - the closest regulatory comparables to K151830.
Hummingbird Tympanostomy Tube System
K221254 · Preceptis Medical, Inc. · Jul 2022
Hummingbird Tympanostomy Tube System
K200952 · Preceptis Medical, Inc. · Jun 2020
TULA Tube Delivery System
K171239 · Tusker Medical · Jun 2017
Ventilation (Tympanostomy) Tubes
K151067 · Medtronic Xomed, Inc. · Jul 2015
HUMMINGBIRD(TM) TYMPANOSTOMY TUBE SYSTEM (TTS)
K142282 · Preceptis Medical · Apr 2015
PRECEPTIS TYMPANOSTOMY TUBE INSERTER
K133921 · Preceptis Medical · Aug 2014