Product Code: KHH FDA class 1 21 CFR 874.1800

Stimulator, Caloric-Air

Ear, Nose, Throat

Caloric-Air Stimulator is a diagnostic device used in otolaryngology and neurotology to deliver controlled streams of warm or cool air into the external ear canal to induce caloric nystagmus, enabling vestibular function testing and evaluation of the vestibulo-ocular reflex. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KHH, regulated under 21 CFR 874.1800, within the Ear, Nose, Throat medical specialty.

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Basic Information

Product Code: KHH
Device Class: FDA class 1
Regulation Number: 874.1800
Medical Specialty: Ear, Nose, Throat
Review Panel: EN
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 7 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K950785	HORTMANN AIRMATIC AIR CALORIC STIMULATOR	Jun 28, 1995	Substantially Equivalent	Jedmed Instrument Co.
K946108	EAR-A-GATOR	Jun 13, 1995	Substantially Equivalent	Life-Tech Intl., Inc.
K941325	WATER IRRIGATOR, W1 200	Aug 09, 1994	Substantially Equivalent	Strong Medical, Inc.
K931608	NCA-200	Jun 22, 1993	Substantially Equivalent	Ics Medical Corp.
K925237	AUTOMATIC CALORIC IRRIGATION SYSTEM	May 05, 1993	Substantially Equivalent	Ics Medical Corp.
K881630	AUTOMATIC CALORIC IRRIGATION SYSTEM	Jun 21, 1988	Substantially Equivalent	Ics Medical Corp.
K822179	FRENZEL EYEGLASSES & RELATED ITEMS	Sep 21, 1982	Substantially Equivalent	Kelleher Corp.