Cleared Traditional

K772066 - PULLEN PLASTIC-PORE PLUGS

K772066 is an FDA 510(k) clearance for PULLEN PLASTIC-PORE PLUGS, manufactured by Richard'S Medical Equip., Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETD cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K772066 · Richard'S Medical Equip., Inc. · Ear, Nose, Throat device
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Dec 1977
Decision
49d
Days
Class 2
Risk

K772066 is an FDA 510(k) clearance for the PULLEN PLASTIC-PORE PLUGS. Classified as Tube, Tympanostomy (product code ETD), Class II - Special Controls.

Submitted by Richard'S Medical Equip., Inc. (Mchenry, US). The FDA issued a Cleared decision on December 20, 1977 after a review of 49 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 Richard'S Medical Equip., Inc. devices

FDA 510(k) Submission Details - K772066

510(k) Number K772066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1977
Decision Date December 20, 1977
Days to Decision 49 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 89d · This submission: 49d
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 K772066.
VENTILATION TUBE. SILI. DONALDSON TYPE
K781258 · Xomed, Inc. · Aug 1978
VENTILATION TUBE TEFLON SHEPARD TYPE
K781259 · Xomed, Inc. · Aug 1978
VENTILATION TUBE SILICONE PAPARELLA TYPE
K781260 · Xomed, Inc. · Aug 1978
PLASTI-PORE BOBBIN DRAIN TUBE, OTOLOGY
K760439 · Richard'S Medical Equip., Inc. · Sep 1976
SPOON-BOBBIN DRAIN TUBE W/ WIRE, OTOLOGY
K760438 · Richard'S Medical Equip., Inc. · Sep 1976