Product Code: LRD FDA class 1 21 CFR 874.5220

Applicator, Ent Drug

Ear, Nose, Throat

An ENT drug applicator is a device used to apply topical medications to the ear, nose, or throat, such as wicks, pledgets, or delivery instruments designed to place or dispense therapeutic agents within these anatomical regions. It is classified as a Class 1 (lowest risk) device, subject only to general controls, representing the least burdensome regulatory category. The product code is LRD, regulated under 21 CFR 874.5220, within the Ear, Nose, and Throat medical specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements under the Quality System regulation.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LRD
Device Class: FDA class 1
Regulation Number: 874.5220
Medical Specialty: Ear, Nose, Throat
Review Panel: EN
Submission Type: 4

Device Characteristics

✓

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 6 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K984345	AROMAPATCH	Mar 19, 1999	Substantially Equivalent	Envis, Inc.
K932522	AMSCO STERILE RECOVERIES SURGICAL PACKS	Sep 09, 1994	Substantially Equivalent	Amsco Sterile Recoveries, Inc.
K942789	MISTASSIST	Aug 12, 1994	Substantially Equivalent	The Merlin Corp.
K940133	THE EXPANDACELL EAR PACK	May 23, 1994	Substantially Equivalent	Denver Splint Co.
K925022	SURGICAL TRAY (STERILE)	Apr 26, 1993	Substantially Equivalent	Customed, Inc.
K920842	AEROSOL DELIVERY SYSTEMS	May 15, 1992	Substantially Equivalent	Hospitak, Inc.